(135 days)
Not Found
No
The summary describes standard electronic stethoscope functionality with sound capture, filtering, visualization, and transmission. There is no mention of AI or ML for analysis or interpretation of the sounds.
No
The provided document describes the Stethophone as a device for detecting, amplifying, filtering, and transmitting auscultation sound data (heart and lungs). It is explicitly stated that Stethophone is a "decision support device" used for the "assessment of chest sounds". While it assists healthcare providers and potentially lay users in acquiring and analyzing sound data, it is not described as directly treating or modifying a disease or condition, which is typically the characteristic of a therapeutic device.
Yes
The device description states, "Stethophone is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments." This directly indicates its role in aiding diagnosis. While it doesn't make a diagnosis itself, it provides the data and visualization tools necessary for clinicians to perform an assessment, which is a key part of the diagnostic process.
No
The device description explicitly states it uses the smartphone microphone for capturing chest sounds, indicating reliance on a hardware component (the microphone) that is part of the medical device system, even if the core functionality is software-based.
Based on the provided information, the Stethophone device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Stethophone's Function: The Stethophone captures and analyzes sound data from the patient's body (heart and lungs) through a microphone. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for detecting, amplifying, filtering, and transmitting auscultation sound data for clinical assessment. This is a form of physical examination, not an in vitro diagnostic test.
Therefore, the Stethophone falls under the category of a medical device used for physical examination and sound analysis, not an IVD.
N/A
Intended Use / Indications for Use
Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.
Product codes
DQD
Device Description
Stethophone is an electronic stethoscope software application that operates on smartphones. Stethophone is designed for use by both healthcare professionals and home users.
Stethophone enables the capture and amplification of chest sounds for real-time or recorded listening. Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization all assist with sound analysis.
Stethophone is designed to assist healthcare providers both in hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in cloud for later analysis. It also enables home users to record and send chest sounds to their physicians.
Stethophone is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment is performed by healthcare providers, while sound capturing can be performed by both healthcare providers and home users.
Key product features:
- Capturing chest sounds using the smartphone microphone:
- Real-time listening to chest sounds,
- Recording of chest sounds,
- Sending examinations to specialists for assessment
- Two modes of sound visualization: oscillogram and spectrogram, and
- Selection of three audio filters for listening:
- Bell: Traditional filter used for low frequency sounds,
- Diaphragm: Traditional filter used for higher frequency sounds of heart and lungs, and
- Starling: Filter for listening to the full frequency of chest sounds.
Collectively, these features enable a healthcare professional to examine and monitor patients, seek out second opinions from specialists, and use the device in a telemedicine context.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Heart and lungs
Indicated Patient Age Range
Adults
Intended User / Care Setting
Professional or lay users in a clinical or nonclinical environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Sparrow Acoustics Inc. submitted performance testing information in this 510(k) to demonstrate safety and efficacy of Stethophone, to validate that the device meets predetermined specifications and performs according to pre-specified acceptance criteria, and to support the substantial equivalence determination.
Testing includes repeatability and reproducibility tests, performance tests using an anechoic chamber, internal tests run by a medical analysts' team, tests involving lay users and external medical specialists with auscultation experience.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 12, 2023
Sparrow Acoustics Inc. Nadia Ivanova Chief Product Officer 2416 Natura Dr Lucasville, NS B4B 0X3 Canada
Re: K231551
Trade/Device Name: Stethophone Regulation Number: 21 CFR 870.1875 Regulation Name: Stethoscope Regulatory Class: Class II Product Code: DQD Dated: Mav 29, 2023 Received: May 30, 2023
Dear Nadia Ivanova:
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 you, 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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert T. Kazmierski -S
for
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Stethophone
Indications for Use (Describe)
Stethophone is an electronic stethoscope that enables detection, amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.
Type of Use (Select one or both, as applicable)
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
Image /page/3/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue, sans-serif font. To the right of the word is a graphic of a bird inside of a circle, with sound waves emanating from the circle. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, gray, sans-serif font.
K231551 - 510(k) SUMMARY
-
- Summary Date: May 31, 2023
-
- Submitter: Sparrow Acoustics Inc. 2416 Natura Dr. Lucasville, NS Canada, B4B 0X3 Tel: +1 (902) 989-3908
-
- Correspondent: Nadia Ivanova
-
- Device Trade Name: Stethophone
- Device Common Smartphone stethoscope ട. Name:
-
- Classification: Electronic Stethoscope 21 CFR 870.1875(b) Class II Product Code: DQD Panel: Cardiovascular
-
- Intended Use/ Stethophone is an electronic stethoscope that enables detection, Indications for Use: amplification, filtering, and transmission of auscultation sound data (heart and lungs), whereby a clinician at one location can listen to the auscultation sounds of a patient acquired on site or at a different location. Stethophone is intended for use on adult patients. Stethophone is intended to be used by professional or lay users in a clinical or nonclinical environment. Stethophone is not intended for self-diagnosis.
-
- Device Description: Stethophone is an electronic stethoscope software application that operates on smartphones. Stethophone is designed for use by both healthcare professionals and home users.
Stethophone enables the capture and amplification of chest sounds for real-time or recorded listening. Cloud storage with sound record sending capabilities, filtering for selected frequency ranges, and visualization all assist with sound analysis.
Stethophone is designed to assist healthcare providers both in hearing and visualizing heart and lung sounds during a physical examination of a patient and in storing recorded sounds in cloud for later analysis. It also enables home users to record and send chest sounds to their physicians.
Stethophone is a decision support device used for the assessment of chest sounds of adult patients in clinical and non-clinical environments. Assessment is performed by healthcare providers, while sound capturing can be performed by both healthcare providers and home users.
4
Image /page/4/Picture/1 description: The image shows the logo for Sparrow Acoustics. The logo features the word "SPARROW" in a light blue sans-serif font, with the letter "O" replaced by a stylized image of a bird in a circle. Below the word "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font.
Kev product features:
- · Capturing chest sounds using the smartphone microphone:
- Real-time listening to chest sounds, O
- Recording of chest sounds, o
- · Sending examinations to specialists for assessment
- · Two modes of sound visualization: oscillogram and spectrogram, and
- · Selection of three audio filters for listening:
- Bell: Traditional filter used for low frequency sounds, O
- Diaphragm: Traditional filter used for higher frequency o sounds of heart and lungs, and
- Starling: Filter for listening to the full frequency of chest O sounds.
Collectively, these features enable a healthcare professional to examine and monitor patients, seek out second opinions from specialists, and use the device in a telemedicine context.
| Predicate Devices: | |
|---|---|
| Stethophone v1 | |
| 510(k) Number: K222871 | |
| Manufacturer: Sparrow Acoustics Inc. | |
| Product Code: DQD | |
| Classification: 870.1875 | Eko CORE |
| 510(k) Number: K200776 | |
| Manufacturer: Eko Devices, Inc. | |
| Product Code: DQD | |
| Classification: 870.1875 |
-
- Comparison to The comparison chart below provides evidence to facilitate the substantial Predicates: equivalence determination between Stethophone to the predicate devices with respect to intended use, technological characteristics, and principles of operation.
| | Stethophone | Stethophone v1
(primary) | Eko CORE | Comments |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | | | | |
| Classification | Class II device | Class II device | Class II device | Same |
| Regulation | 21 CFR
870.1875(b) | 21 CFR
870.1875(b) | 21 CFR 870.1875(b) | Same |
| Product code | DQD | DQD | DQD | Same |
| Device | Stethoscope,
Electronic | Stethoscope,
Electronic | Stethoscope,
Electronic | Same |
| FDA Clearance | Pending | K222871 | K200776 | |
| Intended Use/Indications for Use | | | | |
| Intended
Use/Indications
for Use | Stethophone is an
electronic
stethoscope that
enables detection,
amplification,
filtering, and
transmission of
auscultation sound
data (heart and
lungs), whereby a
clinician at one
location can listen | Stethophone v1 is
intended for
medical diagnostic
purposes only. It
may be used for
detection and
amplification of
sounds from the
heart and lungs
with the use of
selective frequency
ranges. It can be | The Eko CORE is an
electronic
stethoscope that
enables
amplification,
filtering, and
transmission of
auscultation sound
data (heart, lungs,
bowel, arteries, and
veins), whereby a
clinician at one | Substantially
Equivalent |
| | | | | |
| | sounds of a patient
acquired on site or
at a different
location.
Stethophone is
intended for use on
adult patients.
Stethophone is
intended to be used
by professional or
lay users in a
clinical or
nonclinical
environment.
Stethophone is not
intended for self-
diagnosis. | undergoing
physical
assessment. | can listen to the
auscultation
sounds of a patient
on site or at a
different location on
the network. Eko
CORE is intended for
use on pediatric and
adult
patients. The Eko
CORE is intended to
be used by
professional users in
a clinical
environment or by
lay users in a
nonclinical
environment. The
device is not
intended for self-
diagnosis. | |
| Prescription/OTS | Prescription and
OTC | Prescription | Prescription and
OTC | Same |
| Population Type | Adults | Adults | Pediatric and adults | Same with
Stethophone
v1, narrower
population
than Eko
CORE, which
doesn't affect
safety and
performance
for the
proposed
intended use |
| Principles of Operation | | | | |
| Form Factor | Device that is held
in the Doctor's
hand is the form of
the smartphone | Device that is held
in the Doctor's
hand is the form of
the smartphone | Attachment to an
analog stethoscope | Same as
Stethophone
v1. Different
than Eko
CORE, which
doesn't affect
safety and
performance |
| Dedicated
Device vs.
iPhone | Operates on
iPhone smartphone
using its hardware
and operating
system | Operates on
iPhone smartphone
using its hardware
and operating
system | Dedicated
proprietary hardware
(Attachment to an
analog stethoscope) | Same as
Stethophone
v1. Different
than Eko
CORE, which
doesn't affect
safety and
performance |
| iPhone model
Compatibility | 6s, 6S Plus, SE 1st
generation, 7, 7
Plus, 8, 8 Plus, X, | 6s, 6S Plus, SE 1st
gen, 7, 7 Plus, 8, 8
Plus, X, XS, XS | Any model | Stethophone is
available for a
larger number |
| | XS, XS MAX, XR,
SE 2nd generation,
11, 11 Pro, 11 Pro
Max, 12, 12 Pro, 12
Mini, 12 Pro Max,
13 mini, 13, 13 Pro,
13 Pro Max, SE 3rd
generation, 14, 14
Pro, 14 Pro Max | MAX, XR, SE 2
generation, 11, 11
Pro, 11 Pro Max,
12, 12 Pro, 12 Mini,
12 Pro Max, 13
mini, 13, 13 Pro, 13
Pro Max | | of iPhone
models than
Stethophone
v1, which may
affect
availability, but
doesn't affect
safety and
performance
as
stethoscopes |
| Software
Platform | iOS | iOS | iOS, Android | Same as
Stethophone
v1. narrower
than Eko
CORE, which
may affect
availability, but
doesn't affect
safety and
performance
as
stethoscopes |
| Sound Type | Heart, lungs | Heart, lungs | Heart, lungs, bowel,
arteries, and veins | Same as
Stethophone
v1. narrower
than Eko
CORE, which
may affect
availability, but
doesn't affect
safety and
performance
for the
proposed
intended use |
| Signal Input
Method | Uses microphone
of the smartphone
to acquire a sound | Uses microphone
of the smartphone
to acquire a sound | Uses attached
analog stethoscope
to acquire sound and
smartphone to record
sound | Same as
Stethophone
v1. Different
than Eko
CORE, which
doesn't affect
safety and
performance |
| Audio Output
Method | Headphones | Headphones | Eartubes of the
attached analog
stethoscope.
Bluetooth
headphones paired
with Eko App
installed on a
smartphone can also
be used | Same as
Stethophone
v1, equivalent
to Eko CORE |
| Record and
Playback
Sounds | Yes | Yes | Yes | Same |
| Real-Time
Auscultation | Yes | Yes | Yes | Same |
| Filter Selection | Yes | Yes | Yes | Same |
| Digital Signal
Processing
(DSP) | Yes | Yes | Yes | Same |
| Display | Smartphone screen | Smartphone screen | Smartphone screen
via Eko App | Same |
| Sound
Visualization | Yes | Yes | Yes | Same |
| Technical Characteristics | | | | |
| Frequency
Response | Stethophone picks
up and amplifies
the sound between
20 and 2000 Hz.
Based on the
selected audio
filter, specific
frequency ranges
are further
emphasized:
Bell filter
emphasizes range
from 25 to 300 Hz
Diaphragm filter
emphasizes
frequency spectrum
range 170-850 Hz,
Starling filter works
between 60 -1400
Hz. | Stethophone v1
picks up and
amplifies the sound
between 20 and
2000 Hz. Based on
the selected audio
filter, specific
frequency ranges
are further
emphasized:
Bell filter
emphasizes range
from 25 to 300 Hz
Diaphragm filter
emphasizes
frequency spectrum
range 170-850 Hz,
Starling filter works
between 60 -1400
Hz. | The default filter is
Wide but Cardiac
and Pulmonary filters
can also be selected
to allow the lower
and higher
frequencies to be
emphasized in the
sound profile,
respectively | Same with
Stethophone
v1;
substantially
equivalent to
Eko CORE |
| Volume Control | Yes | Yes | Yes | Same |
| Battery | Uses a built-in
battery of a
smartphone | Uses a built-in
battery of a
smartphone | Uses a built-in
battery | Same with
Stethophone
v1;
substantially
equivalent to
Eko CORE |
| Recording
Lengths | 20 sec | 20 sec | 15-120 sec | Same with
Stethophone
v1;
substantially
equivalent to
Eko CORE |
| Available Sound
Visualization | Spectrogram,
oscillogram | Spectrogram,
oscillogram | Oscillogram | Same with
Stethophone
v1;
substantially
equivalent to
Eko CORE |
| Ability to Zoom | Yes | Yes | Yes | Same |
5
Image /page/5/Picture/0 description: The image shows the logo for Sparrow Acoustics. The logo features the word "SPARROW" in large, light blue sans-serif font, with a stylized image of a bird inside a circle replacing the second "R". Below "SPARROW" is the word "ACOUSTICS" in a smaller, sans-serif font, with the letters spaced out.
Stethophone K231551
6
Image /page/6/Picture/0 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside the second "R". Below "SPARROW", the word "ACOUSTICS" is written in smaller, light blue letters.
Stethophone K231551
7
Image /page/7/Picture/0 description: The image is a logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside of a circle in the middle of the word. Below the word "SPARROW" is the word "ACOUSTICS" written in smaller, light blue letters.
Stethophone K231551
8
Image /page/8/Picture/1 description: The image shows the logo for Sparrow Acoustics. The word "SPARROW" is written in large, light blue letters, with a stylized image of a bird inside the "O". Below "SPARROW" is the word "ACOUSTICS" written in smaller, light blue letters. The logo is clean and modern, with a focus on the company name and a subtle visual element.
| 11. | Performance Data: | Sparrow Acoustics Inc. submitted performance testing information in this
510(k) to demonstrate safety and efficacy of Stethophone, to validate
that the device meets predetermined specifications and performs
according to pre-specified acceptance criteria, and to support the
substantial equivalence determination. |
|-----|------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | Testing includes repeatability and reproducibility tests, performance
tests using an anechoic chamber, internal tests run by a medical
analysts' team, tests involving lay users and external medical specialists
with auscultation experience. |
| 12. | Biocompatibility
Testing: | Not Applicable (Standalone Software) |
| 13. | Sterilization & Shelf-
life Testing: | Not Applicable (Standalone Software). Therefore, it is a non-sterile
device and shelf-life is not applicable to this device because of low
likelihood of time-dependent product degradation. |
| 14. | Electrical safety and
electromagnetic
compatibility (EMC): | Not Applicable (Standalone Software). Therefore, there is no source of
risk for electrical safety or electromagnetic compatibility associated
directly with the device. |
| 15. | Animal Study: | Animal performance testing was not required to demonstrate safety and
effectiveness of the device. |
| 16. | Clinical Performance
Testing: | Clinical testing was not required to demonstrate the safety and
effectiveness of the device. |
| 17. | Statement of
Substantial
Equivalence: | Stethophone and the predicates have the same intended use and
similar indications, technological characteristics, and principles of
operation. The minor differences do not present different questions of
safety or effectiveness than the predicate device. Performance data
demonstrates that Stethophone is as safe and effective as the predicate
devices. Thus, Stethophone is substantially equivalent to the predicate
devices. |
This summary of 510(k) safety and effectiveness information is submitted in accordance with the
requirements of 21 CFR §807.92.