The DynoSense Vital Sign Measuring System is intended to record, transfer, store and display of single lead electrocardiography (ECG), heart rate (HR), functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), and oral body temperature (TEMP). The device comes in contact with the patient for approximately 60 seconds at each use. This system is for spot checking and does not have continuous monitoring capability or any alarm features.

This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition.

This system makes no specific diagnosis. The device is for single patient use.

Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device.

Device Description

The DynoSense Vital Sign Measuring System is a battery-powered, handheld, personalized single patient use vital sign measuring apparatus. The user must hold the Device with their left hand. Functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR) measurements are based on transmittance of light through the index finger. Respiration rate (RR) measurements are based on pressure change at the aperture opening during breathing. Oral temperature (TEMP) is measured via sublingual and lingual contact with the thermometer tip. ECG and heart rate (HR) measurements are obtained via completing an electrical path across the left side of the chest. Vital sign data are communicated to a Bluetooth-capable mobile platform for forwarding to the cloud application for processing and storage.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the DynoSense Vital Sign Measuring System, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria & Reported Device Performance

The document provides performance data for several vital signs, primarily referencing compliance with ISO standards and clinical/bench agreement studies, rather than explicit numerical acceptance criteria for each measurement. However, accuracy claims are stated for some parameters.

Acceptance Criteria (Target/Standard)	Reported Device Performance (Achieved)	Study Type / Standard
ECG and Heart Rate:
Ability to produce ECG waveform & HR measurements as per ISO 60601-2-47:2012.	Bench agreement testing as per ISO 60601-2-47:2012. ECG and Heart Rate algorithm tested according to the requirements of IEC 60601-2-47.	Bench Agreement Study (ISO 60601-2-47:2012, IEC 60601-2-47)
Heart rate Accuracy: ±2 bpm or ± 2%, whichever is larger (from Predicate)	±2 bpm or ± 2%, whichever is larger	Bench Agreement Study (ISO 60601-2-47:2012, IEC 60601-2-47)
SpO2 Measurements:
Ability to make pulse oximetry measurements as per ISO 80601-2-61:2011.	Clinical agreement study conducted, as per ISO 80601-2-61:2011.	Clinical Agreement Study (ISO 80601-2-61:2011)
SpO2 Accuracy: 70%-100% ±2% (Claimed, better than predicate's ±3%)	70%-100% ±2%	Clinical Agreement Study (ISO 80601-2-61:2011)
Pulse Rate Measurements:
Ability to make pulse rate measurements (per ISO 80601-2-61:2011).	Bench agreement study between the System and a pulse rate simulator was performed, and clinical agreement study was performed. Both studies were conducted per ISO 80601-2-61:2011.	Bench Agreement Study & Clinical Agreement Study (ISO 80601-2-61:2011)
PR Accuracy: ±2 bpm or ±2%, whichever is greater (from Predicate)	±2 bpm or ±2%, whichever is greater	Bench Agreement Study & Clinical Agreement Study (ISO 80601-2-61:2011)
Respiration Rate Measurements:
Ability to calculate a respiration rate. Accuracy: ± 1.5 bpm, or ± 4%, whichever is greater (from predicate)	Clinical agreement study conducted. Accuracy: ± 1.5 bpm, or ± 4%, whichever is greater.	Clinical Agreement Study
Temperature Measurements:
Ability to validate temperature measurements as per ISO 80601-2-56:2012. Calibration Accuracy: ± 0.2° C (Adjusted mode) (from predicate)	Clinical agreement study conducted, as per ISO 80601-2-56:2012. Calibration Accuracy: ± 0.2° C (Adjusted mode).	Clinical Agreement Study (ISO 80601-2-56:2012)
Usability: Ability of laypeople to read and understand System instructions and simulate normal use without prior training.	Testing was conducted to evaluating the ability of laypeople to read and understand the System instructions for use, and subsequently simulate normal use of the System without prior training.	Usability Study

2. Sample Size and Data Provenance for Test Set

Sample Size: The document does not explicitly state the numerical sample size for the test set for any of the studies (clinical agreement or bench agreement). It generally refers to "a clinical agreement study" or "bench agreement testing."
Data Provenance: Not specified. It's unclear if the data was collected nationally or internationally, or if it was retrospective or prospective.

3. Number of Experts and Qualifications for Ground Truth

The document does not mention the use of experts to establish ground truth.
The ground truth for most vital sign measurements in these types of studies is typically established by comparing the device's readings against a highly accurate reference standard (e.g., a calibrated simulator for bench tests, or established clinical methods/devices for clinical studies).

4. Adjudication Method for Test Set

Not applicable. The document describes direct performance testing against standards or reference devices, not a scenario requiring expert adjudication of qualitative data.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed. This device measures vital signs directly and is not an imaging AI diagnostic aid that would typically involve human readers interpreting AI results.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

Yes, the performance studies described are essentially standalone (algorithm only) performance studies. The device measures vital signs automatically. The studies validate the device's ability to accurately measure ECG, HR, SpO2, PR, RR, and TEMP against established standards or reference methods. The usability study is about a human interacting with the system, but the core vital sign measurement performance is standalone.

7. Type of Ground Truth Used

For Bench Agreement Studies (ECG, HR, Pulse Rate): The ground truth was established using bench agreement testing as per ISO 60601-2-47:2012 and comparison against a pulse rate simulator (for PR). This implies highly controlled, synthetic data or precise physical models.
For Clinical Agreement Studies (SpO2, Pulse Rate, Respiration Rate, Temperature): The ground truth was established through a clinical agreement study for each parameter, adhering to relevant ISO standards (e.g., ISO 80601-2-61:2011 for SpO2/PR, ISO 80601-2-56:2012 for Temperature). This means the device's measurements were compared against accepted clinical reference methods/devices for those vital signs, usually involves real patient data.
For Usability Study: The ground truth was the successful simulation of normal use by laypeople based on instructions for use.

8. Sample Size for Training Set

The document does not explicitly mention the sample size for a training set. For vital signs monitoring devices, the "training" (development and calibration) might involve iterative testing and refinement, but it's not typically described in terms of a distinct, formalized "training set" as it would be for deep learning AI models. The standards compliance and clinical/bench studies primarily focus on validation/testing.

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

Since a distinct "training set" and its ground truth establishment are not detailed in the provided document, this information is not available. Device development and calibration would typically involve laboratory measurements and comparisons to known standards, which effectively serve as the "ground truth" for the device's internal algorithms during its design and optimization phases.

Summary

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August 2, 2019

DynoSense Corp. Saeed Azimi CEO 15166 Los Gatos Blvd Los Gatos, California 95032

Re: K190090

Trade/Device Name: DynoSense Vital Sign Measuring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DOA, DPS, FLL, DRT, MNR Dated: June 27, 2019 Received: July 2, 2019

Dear Saeed Azimi:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 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.

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

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Indications for Use

510(k) Number (if known) K190090

Device Name Dynosense Vital Sign Measuring System

Indications for Use (Describe)

This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition.

This system makes no specific diagnosis. The device is for single patient use.

Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device.

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)

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510(K) SUMMARY

In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the DynoSense Vital Sign Measuring System is provided below:

Device Common Name:	Monitor, Physiological, Patient (Without ArrhythmiaDetection or Alarms)
Device Trade Name:	DynoSense Vital Sign Measurement System
Applicant:	DynoSense Corp.15166 Los Gatos BlvdLos Gatos, CA 95032
Contact:	Saeed AzimiCEODynoSense Corpsazimi@dynosense.comPhone: (650) 397-6105Fax: (650) 397-6013
Prepared by:	Saeed AzimiDynoSense Corp(650) 397-6013sazimi@dynosense.com
Date Prepared:	December 24th, 2018
Classification Regulation:	870.2300, Class II
Classification Name:	Cardiac monitor (including cardiotachometer and ratealarm)
Panel:	Cardiovascular
Primary Product Code:	MWI
Secondary Product Codes:	DQA, DPS, FLL, DRT, MNR
Predicate Devices:	Primary: CheckMe Pro Health Monitor (K150869)Secondary: Welch Allyn Spot Vital Signs Monitor(K132808)

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K190090

Page 2 of 8

Reference Devices:

ABL-90 FLEX (K120197)
· Fluke ProSim 8 Vital Simulator (K110429)
· Nellcor Bedside SpO2 Patient Monitoring System (K142865)
· Capnostream20p (K101995)
· Welch Allyn Spot Vital Signs Monitor (K022163)
· MEDI-TRACE(R) 500 ECG ELECTRODE (K945479)
· EDAN PC-ECG SE1010 EKG (K131819)

INDICATIONS FOR USE: 1.

"The DynoSense Vital Sign Measuring System is intended to record, transfer, store and display of single lead electrocardiography (ECG). heart rate (HR). functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate (PR), respiration rate (RR), and oral body temperature (TEMP). The device comes in contact with the patient for approximately 60 seconds at each use. This system is for spot checking and does not have continuous monitoring capability or any alarm features.

This system is intended for patients 18 years and older in the home environment. It is intended for use with patients who are well perfused and during no motion condition.

This system makes no specific diagnosis. The device is for single patient use.

Users with implanted pacemakers and/or implanted cardio-defibrillators (ICDs) are not recommended to use the device."

DEVICE DESCRIPTION: 2.

STERILIZATION, SHELF LIFE, CLEANING, REUSE: 3.

The System is delivered and used non-sterile. The System is intended to be single patient-only, and reusable.

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4. BIOCOMPATIBILITY:

The System is a surface device and only includes components which are for limited contact (≤ 24h) and are either intact skin-contacting or mucosal membrane-contacting. The materials were tested in accordance with ISO 10993.

PERFORMANCE DATA: 5.

The following performance testing was provided to support the substantial equivalence of the subject device:

ECG and Heart Rate Measurements: To validate the ability of the System to produce ECG . waveform and heart rate measurements, bench agreement testing as per ISO 60601-2-47:2012. The ECG and Heart Rate algorithm tested according to the requirements of IEC 60601-2-47.
SpO2 Measurements: To validate the ability of the System to make pulse oximetry ● measurements, a clinical agreement study was conducted, as per ISO 80601-2-61:2011.
. Pulse Rate Measurements: To validate the ability of the System to make pulse rate measurements a bench agreement study between the System and a pulse rate simulator was performed, and clinical agreement study was performed. Both studies were conducted per ISO 80601-2-61:2011.
Respiration Rate Measurements: To validate the ability of the System to calculate a ● respiration rate, a clinical agreement study was conducted.
Temperature Measurements: To validate temperature measurements, a clinical agreement study was conducted, as per ISO 80601-2-56:2012.
Usability: Testing was conducted to evaluating the ability of laypeople to read and understand the System instructions for use, and subsequently simulate normal use of the System without prior training.

SOFTWARE DOCUMENTATION: 6.

Software documentation for a Moderate Level of Concern device is provided in support of the System.

ELECTRICAL SAFETY TESTING: 7.

The DynoSense Vital Signs Measuring System was evaluated as per ANSI / AAMI 60601-1:2005 + A1:2012, and found to be compliant.

ELECTROMAGNETIC COMPATIBILITY TESTING: 8.

The DynoSense Vital Signs Measuring System was evaluated as per IEC 60601-1-2:2014, and found to be compliant.

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K190090 Page 4 of 8

9. STANDARDS:

Table 1 provides the complete list of standards that are used in the 510(k) to establish device performance and support substantial equivalence:

Standard	Title
ISO 10993-1:2009	Biological Evaluation of Medical Devices - Part 1: Evaluation and testing withina risk management process
ISO 10993-5:2009	Biological Evaluation of Medical Devices - Part 5: Tests For In VitroCytotoxicity
ISO 10993-10:2010	Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skinsensitization;
ISO 10993-12:2012	Biological Evaluation of Medical Devices - Part 12: Sample preparation andreference materials
AAMI / ANSI 60601-1:2005 + A1:2012	Medical electrical equipment - Part 1: General requirements for basic safety andessential performance
IEC 60601-1-11: 2015	Medical electrical equipment - Part 1-11: General requirements for basic safetyand essential performance -- Collateral standard: Requirements for medicalelectrical equipment and medical electrical systems used in the home healthcareenvironment
IEC 60601-1-2:2007	Medical electrical equipment - Part 1-2: General requirements for basic safetyand essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
IEC 60601-1-2:2014	Medical electrical equipment - Part 1-2: General requirements for basic safetyand essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
AAMI / ANSI 60601-2-47:2012	Medical electrical equipment - Part 2-47: Particular requirements for the basicsafety and essential performance of ambulatory electrocardiographic systems
AAMI / ANSI 60601-2-49:2011	Medical electrical equipment - Part 2-49: Particular requirements for the basicsafety and essential performance of multifunction patient monitoring equipment
ISO 80601-2-56:2012	Medical electrical equipment - Part 2-56: Particular requirements for basic safetyand essential performance of clinical thermometers for body temperaturemeasurement
ISO 80601-2-61:2011	Medical electrical equipment - Particular requirements for basic safety andessential performance of pulse oximeter equipment.

List of Standards Table 1:

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10. SUBSTANTIAL EQUIVALENCE DISCUSSION

The primary predicate device is the CheckMe Pro Health Monitor (cleared under K150869); the secondary predicate device is the Welch Allyn Spot Vital Signs Monitor (cleared under K 132808; this device is also a reference device for temperature measurement validation).

Technological Comparison			Substantial Equivalenceto Predicate device
	Subject Device	Predicate Device
510(k) Number	Unknown	K150869	NA
Applicant	DynoSense Corp.	Viatom Technology Co.Ltd.	NA
Device Name	DynoSense Vital SignMeasuring System	Checkme Pro HealthMonitor	NA
ClassificationRegulation	870.2300 –Physiological PatientMonitor	870.2300 – PhysiologicalPatient Monitor	Same
PhysiologicalParametersMonitored	ECG, HR, SpO2, PR,Respiration Rate(RR), Temperature	ECG, HR, SpO2,Temperature	Similar
Location	Home	Home and Hospital	Subject device onlysupports Home Use
Rx or OTC	Rx	Rx	Same
Power Supply	RechargeableLithium-Polymerbattery 210 mAh	560mAh rechargeablelithium-ion polymerbattery	Similar
Alarm	No Alarm	No Alarm	Same
Data collectionmemory	Essentially unlimitedstorage in cloud	100 measurementsstorage	Better
Operating modes	Spot-Check	Continuous Recordingand Spot-Check	Subject device onlysupports Spot-check
Comparison of ECG Measurements
Measured ECGParameter	ECG waveform, HeartRate (HR)	ECG waveform, HeartRate (HR)	Same
ECG RhythmClassification	Not included	Not included	Same
ECG Lead Type	Single Lead, 3Contacts	External ECGCable andElectrodes	Similar
Input impedance	>10 M Ohm	> 10 M Ohm	Same
Technological Comparison			Substantial Equivalenceto Predicate device
	Subject Device	Predicate Device
Input dynamicrange	±300mV	±3 mV	Better
Bandwidth	0.67 to 40 Hz	0.05 — 40Hz	Same
A/D conversion	24 bit	16 bit	Better
Sampling Rate	500 Hz	500 Hz	Same
MeasurementTime	<60 seconds	30 seconds	Similar
Display	Not included	400*240 Dot-matrix LCDdisplay	NA
Input	Dry conductiveelectrodes	Dry conduction electrodesand/or external auxiliaryelectrodes	Similar
Heart rate Range	30〜250 bpm	30〜250 bpm	Same
Heart rateAccuracy	±2 bpm or ± 2%,whichever is larger	±2 bpm or ±2%, whicheveris larger	Same
Comparison of SpO2 Measurements
Display Data	SpO2, Pulse Rate (PR)	SpO2, Pulse Rate (PR)		Same
Mode	Spot-Check	Continuous Recordingand Spot-Check		Subject device supportsSpot-check only
Sensor Types	Integrated	Integrated and external		Subject device supportsintegrated sensor only
Population	Patients ≥18 years ofage	Adult and Pediatric(continuous recording onlyfor adult)		Subject device supportspatients ≥18 years of age
SpO2 DisplayRange	0% to 100%	0 - 100%		Same
SpO2 Accuracy	70%-100% ±2%	70%-100%±3%	70%-100%±2%	Similar
SpO2 Resolution	1 %	1 %		Same
PR range	30-250 bpm	30-250 BPM		Same
PR Accuracy	±2 bpm or ±2%,whichever is greater	±2 bpm or ±2%, whicheveris greater		Same
PR Resolution	1 bpm	1 bpm		Same
Comparison of Temperature Measurement and Analysis
MeasurementTechnique	Thermo-resistivesensor	infrared sensor(thermopile)		Same
Technological Comparison
	Subject Device	Predicate Device	Substantial Equivalenceto Predicate device
Measurementsite	Oral	Forehead	Subject device onlysupports Oral
Mode	Predictive (Normal)Mode	Direct (Monitor) Mode	Subject device onlysupports Predictive(Normal) mode
Unit	°C/°F	°F	Subject device onlysupports °F
Measuring range	$30.0° C - 43.0 ° C$	$33.8 ° C - 42.2 ° C(93.2°F to 108.0°F)$	Subject device supportswider range
CalibrationAccuracy	± 0.2° C (Adjustedmode)	± 0.2° C (±0.4°F)	Similar

Table 2: Technological Comparison, System vs. CheckMe Pro

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K190090 Page 7 of 8

Table 3:	Technological Comparison, System vs. Welch Allyn Connex Vital Signs Monitor
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Comparison of Respiration Rate Measurement
510(k) Number	Unknown	K132808	NA
Applicant	DynoSense Corp.	Welch Allyn, Inc.	NA
Device Name	DynoSense Vital SignMeasuring System	Connex Vital SignsMonitor	NA
ClassificationRegulation	870.2300 –Physiological PatientMonitor	870.2300 – PhysiologicalPatient Monitor	NA
Location	Oral	Oral	Same
MeasurementTechnique	Pressure based	Partial pressure-based	Similar
Location	Home	Hospital	Testing conducted on theSystem supports home use
Display Range	4 bpm – 50 bpm	4 bpm – 70 bpm	System supports narrowerrange
MeasurementRange	4 bpm – 50 bpm	6 bpm – 45 bpm	Better
Accuracy	± 1.5 bpm, or ± 4%,whichever is greater	± 1.5 bpm, or ± 4%,whichever is greater	Same

SUBSTANTIAL EQUIVALENCE CONCLUSION 11.

Based on the detailed comparison of specifications to the previously cleared CheckMe Pro Health Monitor (K150869) and the Welch Allyn device (K132808), the functional, performance and clinical testing and conformance with applicable standards as well as the comparison of

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indications, the differences do not raise new questions of safety and effectiveness and the DynoSense Vital Signs Measuring System can be found 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).