Wearable Device, Wearable Package by Current Health Ltd.

The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.

The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.

The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:

· Pulse rate
· Oxygen saturation
· Temperature
· Movement

The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of.

· Respiration rate
· Non-invasive blood pressure
· Lung function & spirometry
· Weight

The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.

The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

Device Description

The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with devices for monitoring of blood pressure, spirometry & lung function, and weight.

The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function, and weight (WEIGHT).

While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature.

In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.g. an office or within the hospital or could be with the patient in their own home.

AI/ML Overview

The provided document does not contain detailed acceptance criteria or the specific study details for validating the device's performance against such criteria. Instead, it lists various "Test Names" and "Test Descriptions" which broadly indicate areas of testing (e.g., electrical safety, EMC, pulse rate testing, SpO2 testing, respiration rate testing, temperature measurement accuracy). However, it does not specify quantitative acceptance thresholds for these performance metrics, nor does it provide the reported device performance in those quantitative terms.

For example, for "Pulse Rate Testing," the description mentions "Validation of the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007." While this indicates the standards followed, it doesn't state what specific accuracy (e.g., within X beats per minute) was achieved or was the acceptance criterion. The "Results" column consistently states "Passed," but without the specific acceptance criteria, it's impossible to determine the benchmark used for passing.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer based on the absence of the requested information:

A table of acceptance criteria and the reported device performance:

Performance Metric	Acceptance Criteria	Reported Device Performance
Electrical Safety	Unspecified; adherence to IEC 60601-1	"Passed"
EMC	Unspecified; adherence to IEC 60601-1-2	"Passed"
Alarm Testing	Unspecified; adherence to IEC 60601-1-8	"Passed"
Pulse Rate Accuracy	Unspecified; adherence to ISO 80601-2-61 and FDA Guidance 2007	"Passed"
SpO2 Accuracy	Unspecified; adherence to ISO80601-2-61 and FDA Guidance 2013	"Passed"
Respiration Rate Accuracy	Unspecified; comparison to end-tidal CO2	"Passed"
Temperature Measurement Accuracy	Unspecified; adherence to ISO 80601-2-56	"Passed"
Battery Life	Unspecified	"Passed"
PDU Buffering Time	Unspecified	"Passed"
Usability	Unspecified; adherence to IEC 62366 and IEC 60601-1-11	"Passed"
Device Ship/Transport	Unspecified; adherence to ASTM D4169	"Passed"
Biocompatibility	Unspecified; adherence to ISO 10993-1	"Passed"
Wireless Coexistence	Unspecified	"Passed"
System V&V	Unspecified	"Passed"
Software V&V	Unspecified	"Passed"

Sample size used for the test set and the data provenance: This information is not provided in the document. The document states "No clinical studies were conducted as part of submission to prove substantial equivalence." The non-clinical tests mention "the system was tested," but do not specify sample sizes for these tests (e.g., how many subjects for pulse rate and SpO2 accuracy, or how many devices for other tests).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
Adjudication method for the test set: This information is not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not provided. The device is a "Wearable Health Monitoring System" and the testing described is primarily about the accuracy of its vital sign measurements and compliance with various standards, rather than evaluating AI assistance for human readers in a diagnostic capacity.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes various "non-clinical tests" and "software verification and validation testing" which would fall under standalone performance. However, specific performance metrics quantifying the algorithm's output (e.g., sensitivity, specificity, accuracy %) against a ground truth are not provided. The results are merely "Passed" for general compliance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physiological parameters, the ground truth would typically be established by a reference method. The document mentions "in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff" for pulse rate and SpO2, and "comparison to respiration rate measured via end-tidal CO2" for respiration rate. These represent established reference methods for ground truth, but the details of their application in the study (e.g., specific devices used for reference, blinded measurements) are not given. For other tests like electrical safety or EMC, the ground truth is adherence to the specified standard.
The sample size for the training set: This information is not provided. The document does not discuss a training set, as it mainly focuses on verification and validation testing rather than the development of AI/ML models that would require training data.
How the ground truth for the training set was established: This information is not provided, as a training set is not discussed.

Summary

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July 12, 2019

Current Health Ltd. Edwin Lindsay QA/RA Manager Playfair House 12A Broughton Street Lane Edinburgh, EH1 3LY United Kingdom

Re: K191272

Trade/Device Name: Current Wearable Health Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MSX, FLL, DQA, BZQ, DRG, BZG Dated: May 6, 2019 Received: May 13, 2019

Dear Edwin Lindsay:

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.

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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 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 (QS) 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 medical devices and radiation-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.

for Nicole Goodsell Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

Device Name

Current Wearable Health Monitoring System

Indications for Use (Describe)

The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring temperature at the upper arm is clinically indicated.

The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:

· Pulse rate
· Oxygen saturation
· Temperature
· Movement

The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of.

· Respiration rate
· Non-invasive blood pressure
· Lung function & spirometry
· Weight

The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

Type of Use (Select one or both, as applicable)

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.

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For Current Wearable Health Monitoring System

510(k) Summary

This 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92.

Submitter's Name:

Current Health Ltd

Submitter's Address:

Playfair House, 12A Broughton Street Lane Edinburgh EH1 3LY

Telephone: +44 (0) 131 560 1137

Establishment Registration Number:

3015134004

Contact Person:

Edwin Lindsay

Telephone +44 (0) 7917134922

Date Prepared:

6th May 2019

Note: snap40 Ltd has recently changed their name to Current Health Ltd.

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For Current Wearable Health Monitoring System

Below summaries the Device Classification Information regarding the Current Wearable Health Monitoring System:

Primary Product Code:

RegulationNumber	Device	DeviceClass	ProductCode	ClassificationPanel
870.2300	System, Network andCommunication,Physiological Monitors	Class 2	MSX	Cardiovascular

Secondary Product Codes:

RequlationNumber	Device	DeviceClass	ProductCode	ClassificationPanel
880.2910	Thermometer, Electronic,Clinical	Class 2	FLL	GeneralHospital
870.2700	Oximeter	Class 2	DQA	Cardiovascular
868.2375	Monitor, BreathingFrequency	Class 2	BZQ	Anesthesiology
870.2910	Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	Class 2	DRG	Cardiovascular
868.1840	Spirometer, Diagnostic	Class 2	BZG	Anesthesiology

Device Trade Name:

Current Wearable Health Monitoring System

Device Common Name:

Current Wearable Health Monitoring System

Intended/ Indications Use:

The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:

. Pulse rate
Oxygen saturation ●
Temperature ●
Movement

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For Current Wearable Health Monitoring System

The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of:

Respiration rate ●
Non-invasive blood pressure .
. Lung function & spirometry
Weight .

The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.

The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.

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For Current Wearable Health Monitoring System

Summary of Substantial Equivalence:

The following predicate devices have been that the Current Wearable Heath Monitoring System can claim equivalence with and these are detailed below

General Comparison

Property	Proposed DeviceCurrent WearableHealth MonitoringSystem	Primary PredicateCurrent WearableHealth MonitoringSystem	Secondary PredicateSpirobank G	Secondary PredicateVivaLnk Fever Scout	Comment
CommonName	System, Network andCommunication,PhysiologicalMonitors	System, Network andCommunication,PhysiologicalMonitors	Spirometer, Diagnostic	Thermometer, Electronic, Clinical	N/A
DeviceManufacturer	Current Health Ltd	Current Health Ltd	M.I.R Medical InternationalResearch	VivaLnk Inc	N/A
DeviceClassification	II	II	II	II	N/A
510(k)Number	N/A	K190073	K072979	K181013	N/A
PrimaryProductCode	MSX	MSX	BZG	FLL	N/A
SecondaryProductCode	FLL DQA BZQ DRGBZG	FLL DQA BZQ DRGBZG	N/A	N/A	N/A
TargetPopulation	Adult	Adult	Adult	Adult & Children	The proposed device andpredicates are identical
Environment	ProfessionalHealthcare Facilities& Home	ProfessionalHealthcare Facilities& Home	Professional HealthcareFacilities & Home	Professional HealthcareFacilities & Home	The proposed device andpredicates are identical
Property	Proposed DeviceCurrent WearableHealth MonitoringSystem	Primary PredicateCurrent WearableHealth MonitoringSystem	Secondary PredicateSpirobank G	Secondary PredicateVivaLnk Fever Scout	Comment
IntendedUse/Indicationfor Use	The Current WearableHealth MonitoringSystem is intendedfor reusable bedside,mobile and centralmulti-parameter,physiologic patientmonitoring of adultpatients inprofessionalhealthcare facilities,such as hospitals orskilled nursingfacilities, or their ownhome. It is intendedfor monitoring ofpatients by trainedhealthcareprofessionals.The Current WearableHealth MonitoringSystem is intended toprovide visual andaudible physiologicmulti-parameteralarms. The CurrentWearable HealthMonitoring System isintended fortemperaturemonitoring wheremonitoringtemperature at theupper arm isclinically indicated.The Current WearableHealth MonitoringSystem is intendedfor continuousmonitoring of thefollowing parameters	The Current WearableHealth MonitoringSystem is intendedfor reusable bedside,mobile and centralmulti-parameter,physiologic patientmonitoring of adultpatients inprofessionalhealthcare facilities,such as hospitals orskilled nursingfacilities, or their ownhome. It is intendedfor monitoring ofpatients by trainedhealthcareprofessionals.The Current WearableHealth MonitoringSystem is intended toprovide visual andaudible physiologicmulti-parameteralarms. The CurrentWearable HealthMonitoring System isintended fortemperaturemonitoring wheremonitoringtemperature at theupper arm isclinically indicated.The Current WearableHealth MonitoringSystem is intendedfor continuousmonitoring of thefollowing parameters	The Spirobank G spirometer isintended to be used by a physician orby a patient under the instruction of aphysician or paramedic. The device isintended to test lung function and canmake spirometry testing in people ofall ages, excluding infants andneonates. It can be used in anysetting.	The wireless Fever ScoutContinuous Monitoringthermometer is a non-invasiveand re-usable electronic devicefor home use and a non-invasiveand single patient use in thehome. This product is intendedfor non-urgent ambulatorycontinuous armpit bodytemperature monitoring fromages 29 days and older.	The intended use and indications foruse of the proposed device and theprimary predicate are identical in thatthey both offer multi-parameterphysiologic monitoring in professionalhealthcare facilities and the home.The intended use and indications foruse of the proposed device and thesecondary predicate, the Spirobank G,are the same in that they bothmonitor lung function and spirometry.The intended use and indications foruse of the proposed device and thesecondary predicate, the VivaLnkFever Scout, are the same in that theyboth monitor temperature.
Property	Proposed DeviceCurrent WearableHealth MonitoringSystemin adults:	Primary PredicateCurrent WearableHealth MonitoringSystemin adults:	Secondary PredicateSpirobank G	Secondary PredicateVivaLnk Fever Scout	Comment
	Pulse rateOxygen saturationTemperatureMovement	Pulse rateOxygen saturationTemperatureMovement
	The Current WearableHealth MonitoringSystem is intendedfor intermittent orspot-checkmonitoring, in adults,of:	The Current WearableHealth MonitoringSystem is intendedfor intermittent orspot-checkmonitoring ofrespiration rate, non-invasive bloodpressure and weightin adults.
	Respiration rateNon-invasive bloodpressureLung function &spirometryWeight	The Current WearableHealth MonitoringSystem is notintended for use inhigh-acuityenvironments, suchas ICU or operatingrooms.
	The Current WearableHealth MonitoringSystem is notintended for use inhigh-acuityenvironments, suchas ICU or operatingrooms.	The Current WearableHealth MonitoringSystem is notintended for use onacutely ill cardiacpatients with thepotential to developlife threateningarrhythmias e.g. veryfast atrial fibrillation.For these patients,they should bemonitored using adevice withcontinuous ECG. TheCurrent Wee
	The Current WearableHealth MonitoringSystem is notintended for use onacutely ill cardiacpatients with thepotential to developlife threateningarrhythmias e.g. veryfast atrial fibrillation.For these patients,
Property	Proposed DeviceCurrent WearableHealth MonitoringSystem	Primary PredicateCurrent WearableHealth MonitoringSystem	Secondary PredicateSpirobank G	Secondary PredicateVivaLnk Fever Scout	Comment
	monitored using adevice withcontinuous ECG. TheCurrent WearableHealth MonitoringSystem is not asubstitute for an ECGmonitor.	Health MonitoringSystem is not asubstitute for an ECGmonitor.
	The Current WearableHealth MonitoringSystem is notintended for SpO2monitoring inconditions of highmotion or lowperfusion.	The Current WearableHealth MonitoringSystem is notintended for SpO2monitoring inconditions of highmotion or lowperfusion.

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Current Health Ltd.

For Current Wearable Health Monitoring System

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For Current Wearable Health Monitoring System

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For Current Wearable Health Monitoring System

There are no technical differences.

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For Current Wearable Health Monitoring System

Device Description:

While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature.

Technological Characteristics:

A comparative review of the Current Wearable Health Monitoring System with the predicate device found that the technology, mode of operation, and general principles for treatment with this device were substantially equivalent.as the predicate device.

Non-Clinical Tests (Performance/Physical Data):

The Current Wearable Health Monitoring System was evaluated for its safety and effectiveness based on the following testing:

Test Name	Test Description	Results
Electrical Safety	The Current Health System was tested to confirmthat it met the applicable standards for electricalsafety (IEC 60601-1)	Passed
EMC	The Current Health System was tested to confirmthat it met the applicable standards forelectromagnetic compatibility (EMC) (IEC 60601-1-2)	Passed
QI Charger Testing	The Current Health Wearable was tested to confirmthe device could be charged using the QI Charger	Passed

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: Wearable Health Monitoring System
For Current Wearable Health Monitoring System

Test Name	Test Description	Results
Environment Testing	The Current Health System was tested to confirmthe storage and operating temperature ranges.	Passed
Alarm Testing	The Current Health System was tested to confirmthat it met the applicable standards for basic safetyand essential performance for alarm systems (IEC60601-1-8)Alarm Function Verification Tests for eachparameter function were performed.	Passed
Pulse Rate TestingValidation of theaccuracy of pulse ratemonitoring	The Current Health System was tested to confirmthe accuracy of pulse rate monitoring of the systemin accordance with ISO 80601-2-61 and the FDAPulse Oximeters - Premarket NotificationSubmissions: Guidance for Industry and FDA Staff.2007	Passed
Battery Testing	The Current Health Wearable Device Battery Lifetesting was performed to determine the battery lifeof the Wearable Device while operating in variousmodes as well as time to fully charge.	Passed
PDU Buffering TimeTesting	The Current Health system was tested to evaluatethe difference between the theoretical maximumPDU buffering time and the observed maximumPDU buffering time.	Passed
Usability Testing	The Current Health System was assessed withregards to usability for compliance with IEC 62366 -Medical devices - Application of usabilityengineering to medical devices and IEC 60601-1-11	Passed
Device Ship/TransportTesting	Ensure device, enclosed in the selected shippingcontainer, meets ASTM D4169 specifications.	Passed
BiocompatibilityTesting	Testing and analysis of the Current Health Systemhas demonstrated compliance to ISO 10993-1:Biological evaluation of medical devices - Guidance	Passed

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For Current Wearable Health Monitoring System

Test Name	Test Description	Results
SpO2 TestingValidation of theaccuracy of SpO2monitoring	Ensure the accuracy and communication of theSpO2 functions within the Current Health system asper ISO80601-2-61 and the FDA SpO2 guidance;Pulse Oximeters-Premarket NotificationSubmissions Guidance for Industry and Food andDrug Staff, March 4, 2013	Passed
Respiratory RateTesting	Ensure accuracy of the Current Health systemmeasurement of respiration rate in comparison torespiration rate measured via end-tidal CO2 in avariety of postures	Passed
TemperatureMeasurementAccuracy	The Current Health System was tested to confirmthe Temperature Measurement Accuracy of thesystem in compliance with ISO 80601-2-56	Passed
Wireless RadioCommunication(Wireless CoexistenceTesting)	The Current Health System was tested to ensuredevice can communicate via wireless radio in itsintended environment	Passed
System Verificationand Validation Testing	The system verification and validation testing wasperformed to verify the software and firmware of theCurrent Health System. This included testing ofintegration and interoperability of the peripheraldevices for blood pressure, axillary temperature,lung function & spirometry and weight.	Passed

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "moderate" level of concern, since a failure or latent design flaw could directly result in minor injury to the patient or operator or a failure or latent flaw could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Animal Studies

No animal studies were conducted as part of submission to prove substantial equivalence.

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For Current Wearable Health Monitoring System

Clinical Studies

No clinical studies were conducted as part of submission to prove substantial equivalence.

Safety and Effectiveness/Conclusion:

Based on the information presented in these 510(k) premarket notifications the Current Wearable Health Monitoring System is considered substantially equivalent. The Current Wearable Health Monitoring System is as safe and effective as the currently marketed predicate devices.

Based on testing and comparison with the predicate devices, the Current Wearable Health Monitoring System indicated no adverse indications or results. It is our determination that the Current Wearable Health Monitoring System is safe, effective and performs within its design specifications and is substantially equivalent to the predicate device.

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).