The eKuore One electronic interface for stethoscope is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application.

It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems.

Device Description

eKuore One is a system formed by eKuore One device and eKuore ONE App. The main purpose of eKuore One device is to digitalize auscultation sounds. The main purpose of eKuore ONE App is to get the acoustic signal from eKuore One device through point to point connection via USB OTG cable. The data transmission via the USB OTG cable provides high data integrity.

eKuore ONE App displays the acoustic signal as a phonogram in real time and allow user to make recordings for later use.

eKuore ONE App detects the eKuore One device automatically once the USB OTG cable is connected.

Once eKuore One device is detected, the application identifies the device and make a connection. Once connected, the application goes to the monitor screen where the phonogram is shown in real time, the data represented in the eKuore ONE App is not processes prior to display.

In the monitor screen, there is a record button. When pressed, it starts a recording with a duration of 15 seconds. Recordings are stored in .wav file format in the internal memory of the connected smartphone/tablet. At the end of the recording process, the application asks the user for a "PatientID" and "Position" only to conform the recording name. The idea is to help the user in the later handling of the recordings.

eKuore ONE App has a recording management screen where it is possible to play, remove and edit a recording. The edition is only for the "PatientID" and "Position". The audio data of one recording can't be modified either shared.

eKuore ONE App has an internal security process to remove any recording with incorrect name format or without the required duration.

Furthermore, eKuore ONE App has a tutorial to help the user and one "About App" screen where access to support is available.

AI/ML Overview

Below is an analysis of the provided FDA 510(k) summary for the eKuore One electronic interface for a stethoscope, focusing on acceptance criteria and supporting studies.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K181882) is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not explicitly state acceptance criteria in the form of quantitative performance thresholds for accuracy, sensitivity, or specificity of detecting specific heart/lung sounds. Instead, the "acceptance criteria" are implicitly met by demonstrating that the eKuore One has similar technical characteristics and performance to the predicate device, the Eko Electronic Stethoscope System (K151319), and that any differences do not raise new questions of safety or effectiveness.

Aspect	Acceptance Criteria (Implicitly met by demonstrating substantial equivalence to predicate)	Reported Device Performance (Summary from submission)
Intended Use	Match the predicate device's intended use.	"The eKuore One electronic interface for stethoscope is intended to be used as a part of a physical assessment of a patient by healthcare professionals for diagnostic decision support in clinical settings. eKuore One is intended for use on pediatric and adult patients. It can electronically filter and transfer sounds to the accompanying mobile software application. It can be used to record heart sounds and cardiac murmurs, bruits, respiratory sounds and abdominal sounds during physical examination in normal patients or those with suspected diseases of the cardiac, vascular, pulmonary or abdominal organ systems." (Identical to predicate)
Technological Characteristics	Similar to the predicate device, with any differences not raising new questions of safety or effectiveness.	Similarities: Compatible Stethoscopes (3M Littmann Cardiology II/III), Digital signal processor, Closed system with mobile app, Same frequency range (20 Hz to 2 KHz), Signal storage, Hardware and software platform (mobile devices/tablets). Differences: Principle of operation (eKuore One digitalizes without amplification, Eko amplifies), Signal transmission (eKuore One wired USB, Eko Bluetooth), Energy Source (eKuore One via smartphone USB, Eko Lithium Ion Battery), Connections (eKuore One USB for communication, Eko USB for charging).
Acoustic Performance	Acoustic performance comparable to the predicate device.	"An acoustic performance comparison between eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System has been performed. Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting both devices with similar acoustic characteristics."
Safety and EMC	Compliance with relevant electrical safety and electromagnetic compatibility standards.	Successful completion of AAMI ANSI 60601-1:2005 and A1:2012 and IEC 60601-1-2 Edition 4: 2014-02 standards.
Software Life Cycle	Compliance with medical device software development standards.	Successful completion of IEC 62304:2015.
Usability	Compliance with usability engineering standards.	Successful completion of AAMI ANSI IEC 62366:2007.
Risk Management	Identification, evaluation, and control of potential hazards.	Compliance with ISO 14971:2007.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a separate "test set" in the context of a clinical study or a labeled dataset for AI evaluation. The non-clinical data primarily involve bench testing for acoustic performance and compliance with relevant standards.

Sample Size for Acoustic Performance: Not explicitly stated as a number of sound recordings or patients. The text mentions "An acoustic performance comparison between eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System has been performed." and "Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully." This suggests a comparative bench test rather than a large clinical sample.
Data Provenance: The studies mentioned are primarily bench tests and compliance testing, not clinical data from patients. Therefore, the concept of "country of origin" or "retrospective/prospective" doesn't directly apply in the same way it would for clinical trials. The manufacturer is Chip Ideas Electronics S.L. from Valencia, Spain.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. The studies described are non-clinical, focusing on technical and acoustic performance against a predicate device and compliance with engineering standards, rather than diagnostic accuracy studies requiring expert-adjudicated ground truth.

4. Adjudication Method for the Test Set

This information is not provided. As the studies are primarily bench tests and engineering compliance, a formal adjudication method for a "test set" with expert consensus would generally not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Reader Improvement

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states "Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device." There is no mention of human reader studies, AI assistance, or effect sizes related to human improvement with AI.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone AI algorithm performance study was not done. The device itself is an electronic interface for a stethoscope that digitizes and transfers sound to a mobile app for healthcare professionals to use. The mobile app displays a phonogram in real-time and allows recording. It does not perform automated diagnostic interpretation or decision-making on its own without human intervention, which would typically be the focus of a standalone algorithm performance study. The device is for "diagnostic decision support in clinical settings", implying human involvement.

7. The Type of Ground Truth Used

For the acoustic performance comparison, the "ground truth" was implicitly the acoustic characteristics and signal acquisition accuracy of the predicate device, the Eko Electronic Stethoscope System. The eKuore One was deemed successful because it presented "similar acoustic characteristics." For the standard compliance tests (e.g., electrical safety, software, usability), the "ground truth" was the requirements and specifications defined by the respective international standards.

8. The Sample Size for the Training Set

This information is not applicable/not provided because the device, as described, is an electronic interface tool and does not appear to incorporate an AI algorithm that requires a "training set" in the conventional machine learning sense for diagnostic purposes. The software displays raw or filtered phonograms and allows recording, but doesn't mention an AI model.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided for the same reason as in point 8. No training set for an AI algorithm is mentioned.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

March 27, 2019

Chip Ideas Electronics S.L Bernardo Plaza Trillo Chief Operating Officer C/ Clariano 8. Entresuelo B Valencia, 46021 SPAIN

Re: K181882

Trade/Device Name: eKuore One electronic interface for stethoscope Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: February 4, 2019 Received: February 8, 2019

Dear Bernardo Trillo:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind vou, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

{1}------------------------------------------------

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shawn W. Forrest -S 2019.03.27 14:42:30 -04'00'

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K181882

Device Name

eKuore One electronic interface for stethoscope

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

SUBMITTER

Submitter name: Chip Ideas Electronics, S.L. C/ Clariano 8, Entresuelo B. Submitter address: 46021 Valencia SPAIN

Contact person: Bernardo Plaza Trillo Phone: +34 640742454 bernardo.plaza@ekuore.com e-mail:

Date Prepared:

2018-03-16

DEVICE

Device Trade Name:	eKuore One electronic interface for stethoscope
Common Name:	ELECTRONIC STETHOSCOPE
Regulation Name:	ELECTRONIC STETHOSCOPE
Regulatory Class:	Class II
Product Code:	DQD
Regulation Number:	870.1875

PREDICATE DEVICE

Predicate Device (S):

Eko electronic Stethoscope System, K151319

{4}------------------------------------------------

l. DEVICE DESCRIPTION

eKuore ONE App displays the acoustic signal as a phonogram in real time and allow user to make recordings for later use.

eKuore ONE App detects the eKuore One device automatically once the USB OTG cable is connected.

In the monitor screen, there is a record button. When pressed, it starts a recording with a duration of 15 seconds. Recordings are stored in * wav file format in the internal memory of the connected smartphone/tablet. At the end of the recording process, the application asks the user for a "PatientID" and "Position" only to conform the recording name. The idea is to help the user in the later handling of the recordings.

eKuore ONE App has an internal security process to remove any recording with incorrect name format or without the required duration.

Furthermore, eKuore ONE App has a tutorial to help the user and one "About App" screen where access to support is available.

{5}------------------------------------------------

Equipment description
Image: eKuore One main piece	eKuore One the main piece. Is the partwhich is attached to the stethoscope.
Image: eKuore One main piece, internal view	eKuore One the main piece, internal view.
Image: eKuore One preparation into the tubing adaptors to the stethoscope	eKuore One preparation into the tubingadaptors to the stethoscope.The first pictogram is for attachment withLittmann Cardiology stethoscopesThe second one is for attachment withLittmann Classic stethoscopes
Image: eKuore One installed into the stethoscope and USB cable	eKuore One installed into the stethoscopeand USB cable to display the digitalsound to the mobile device.
Image: eKuore One real view of complete installation	eKuore One real view of completeinstallation.

{6}------------------------------------------------

ll. INDICATIONS FOR USE

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE lll. PREDICATE DEVICE

The electronic stethoscopes are mainly used on auscultation in the detection of cardiac, respiratory sounds and check other internal organs. These types of devices are used to digitize the data of the auscultation into a mobile device.

In the establishment of substantial equivalence, eKuore One electronic interface for stethoscopes compared to the predicate device K151319 Eko Electronic Stethoscope System:

Elements ofcomparison	eKuore One electronicinterface forstethoscope(Candidate Device)	Eko electronicstethoscope system.(Predicate device)	Comparison
Regulatory data
Regulatory Class	Class II	Class II	Identical topredicate device
Classification name	Electronic Stethoscope	Electronic Stethoscope	Identical topredicate device
Regulation Number	21 CFR 870.1875	21 CFR 870.1875	Identical topredicate device
Product code	DQD	DQD	Identical topredicate device
Manufacturer	Chip Ideas Electronics,S.L.	Eko Devices, Inc.	-
FDA Clearance	Pending	510(k) cleared:K151319	-
Elements ofcomparison	eKuore One electronicinterface forstethoscope(Candidate Device)	Eko electronicstethoscope system.(Predicate device)	Comparison
USE
Indications for use	The eKuore Oneelectronic interface forstethoscope is intendedto be used as a part of aphysical assessment ofa patient by healthcareprofessionals fordiagnostic decisionsupport in clinicalsettings. eKuore One isintended for use onpediatric and adultpatients. It canelectronically filter andtransfer sounds to theaccompanying mobilesoftware application.It can be used to recordheart sounds andcardiac murmurs, bruits,respiratory sounds andabdominal soundsduring physicalexamination in normalpatients or those withsuspected diseases ofthe cardiac, vascular,pulmonary or abdominalorgan systems.	The Eko ElectronicStethoscope System isintended to be used as apart of a physicalassessment of a patientby healthcareprofessionals fordiagnostic decisionsupport in clinicalsettings. Eko is intendedfor use on pediatric andadult patients. It canelectronically amplify,filter and transfer soundsto the accompanyingmobile application forstorage and sharing.It can used to recordheart sounds andcardiac murmurs, bruits,respiratory sounds andabdominal soundsduring physicalexamination in normalpatients or those withsuspected diseases ofthe cardiac, vascular,pulmonary or abdominalorgan systems.	The Indications forUse statement forthe eKuore One isidentical to thepredicate device.
Characteristics			Comparison
Principles of operation	The device consists in amicrophone and someelectronics for theirdigitalization andcodification to astandard format, andsending via USB cableto smartphones andtablets.	Dispositive introduced inan acoustic stethoscopeand gives soundamplification and audiotransmission to asmartphone viaBluetooth that allows theuser to open andplayback sounds in amobile application oncompatible iOSsmartphones andtablets.	Similar to predicatedevicewith the followinggaps:Amplification vsonlydigitalizationRF transmission(Bluetooth) vsUSB cableIOS & Androidvs Android
Elements ofcomparison	eKuore One electronicinterface forstethoscope(Candidate Device)	Eko electronicstethoscope system.(Predicate device)	Comparison
Clinical conditions	Human body soundsrelated	Human body soundsrelated	Identical topredicate device
Use	Electronic stethoscope	Electronic stethoscope	Identical topredicate device
Compatibility	-Littmann 3M CardiologyII/III-Littmann 3M classic II	-Littmann 3M CardiologyII/III-WelchAllyn HarveyElite-ADC601 lines of analogstethoscopes	Similar to predicatedevice
Prescription/OTC	Prescription use	Prescription use	Identical topredicate device
Intended for DirectConnection to Patient	NO	NO	Identical topredicate device
Use environment	Hospitals	Hospitals	Identical topredicate device
Type of users	Health-care personnel	Health-care personnel	Identical topredicate device
Target population	All types of patients	All types of patients	Identical topredicate device
Technicalequivalence
Sound track transferfunction	Yes	Yes	Identical topredicate device
Signal transmissionfor visualization	Wired transmission tocompatiblesmartphones	Bluetooth transmissionto compatiblesmartphones	Different frompredicate device
Energy Source	Provided by smartphonevia USB cable	Lithium Ion Battery	Different frompredicate device
System required	Android device	Android device andApple, Inc	Similar to predicatedevice
Hardware andsoftware platforms	Mobile devices or tables	Mobile devices ortablets	Identical topredicate device
Connections	Micro USB conector tocommunicate with themobile phone	Micro USB conectoronly to charge internalbattery of the device	Different frompredicate device
Frequency range	20 Hz to 2 KHz	20 Hz to 2 kHz	Identical topredicate device
Signal Input Method	Sound was collected viaa Trasnducer. MEMS	Sound waves collectedvia a Transducer.Electro micro-phone	Identical topredicate device
Audio Output Method	Earbuds and 3.5mmJack when connectedwith smartphone	Earbuds and 3.5mmJack when connectedwith smartphone	Identical topredicate device
Elements ofcomparison	eKuore One electronicinterface forstethoscope(Candidate Device)	Eko electronicstethoscope system(Predicate device)	Comparison
Signal Storage	Allows signal storagedepending on technicalfeatures (capacity,...) ofconnected device(smartphone or tablet).	Allows signal storagedepending on technicalfeatures (capacity,...) ofconnected device(smartphone or tablet).	Identical topredicate device
Performancerequirements	Temp range: -10°C to+40°CHumidity range: 0% to90%	The operating range is -10°C to 40°C, and 0% to90% relative humidity	Identical topredicate device
BiologicalEquivalence
Materials	Body: ABS (AcrylonitrileButadiene Styrene)	Body: ABS (AcrylonitrileButadiene Styrene).	Identical topredicate device
Contact with humantissues or body fluids	Does not contactpatient's body. Attachedstethoscope does.	Does not contactpatient's body. Attachedstethoscope does.	Identical topredicate device
Sterility	Not intended to besterilized	Not intended to besterilized	Identical topredicate device

{7}------------------------------------------------

{8}------------------------------------------------

{9}------------------------------------------------

Table 1. Substantial Equivalence Comparison - eKuore One electronic interface for stethoscope and Predicate Device K151319

As seen in the table above, most elements of comparison are identical between both proposed and predicate devices. The most relevant similarities of eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System include the following technological elements:

. Compatible Stethoscopes: Both are designed to work with 3M Littmann Cardiology II/III stethoscopes. They may also work with many other brands models.
. Digital signal processor: Both the eKuore One and Eko Core use the stethoscope attached to the device to filter internal organ sounds from the patient.
. System configuration: Both are closed systems providing a mobile app software that displayed the signal from the internal organ sounds into a mobile device.

{10}------------------------------------------------

. Frequency range The eKuore One and Eko Core use the same frequency range that is the place where the cardiac and pulmonary sounds are located.
. Signal storage: The eKuore One and Eko Core allow recording auscultation sounds in the application software.
. Hardware and software platform: The eKuore One and Eko Core are compatible with mobile devices software and they can be used on mobile and tablet app software.

The following technological differences exist between the subject and predicate devices:

· Principle of operation:
The eKuore One electronic digitalize the internal organ sounds and is intended to not alter the auscultation sounds captured by the stethoscope attached whilst the equivalent device Eko Core Electronic Stethoscope system amplify the organ sounds being able to alter the recording auscultation sounds
· Signal transmission for visualization:
The eKuore One electronic interface for stethoscope not require enable Bluetooth pairing with the device to transmit sounds whereas the Eko Electronic Stethoscope system used Bluetooth to transmit signal sounds into a mobile device.
Energy Source: .
The eKuore One obtain the energy source by smarthphone via USB cable whereas the Eko Core used Lithium Ion Battery.
Connections: .
The connectios of eKuore One use a micro USB to communicate with the mobile phone while Eko Core need micro USB connector to charge internal battery of the device.

eKuore One electronic interface for stethoscope is a simpler variant of the Eko

{11}------------------------------------------------

electronic stethoscope system predicate design and with same indications for use. Technological differences as established above have been addressed in the different bench tests performed on the proposed device to provide data to support that they do not affect the safety and effectiveness of the device relative to the predicate. In conclusion eKuore One has similar intended uses as the predicate device and has very similar technological characteristics.

Summary discussion of non-clinical data:

The proposed device has been designed, developed, tested, verified and validated according to documented procedures and specific protocols in line with the following FDA guidance documents:

Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
General requirements for basic safety standard requirements for medical electrical equipment test have been successfully complete following standard of AAMI ANSI 60601-1:2005 and A1:2012 and IEC 60601-1-2 Edition 4: 2014-02

Integration verification and validation testing have been successfully complete following standard IEC 62304:2015.

Usability testing requirements have been evaluated and successfully met as per standards AAMI ANSI IEC 62366:2007.

Design and development included identification, evaluation and control of potential hazards as per standard ISO 14971:2007.

An acoustic performance comparison between eKuore One electronic interface for stethoscope and Eko Electronic Stethoscope System has been performed. Device signal acquisition accuracy and acoustic transmission disturbance has been evaluated and successfully, presenting both devices with similar acoustic characteristics.

Summary discussion of clinical data:

Non-clinical test data are submitted to support this premarket notification and to establish the decision concerning adequate safety and performance of the predicate device.

IV. CONCLUSIONS

Based on the information provided in this premarket notification, Chip Ideas Electronics S.L., concludes that eKuore One electronic interface for stethoscope is substantially equivalent to the listed legally marketed predicate device.

Regulation Number and Section

§ 870.1875 Stethoscope.

(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.