The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardioaraphy (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.

Device Description

The ANNE Chest Sensor is a skin-mounted, bio-integrated sensor that collects real-time biosignals including electrocardiography (ECG), 3-axis accelerometry, and temperature to measure vital signs such as heart rate, respiratory rate, body position, fall detection, and skin temperature. The sensor communicates via Bluetooth to the Sibel SDK, which may be integrated within software applications for the display and storage of data. The ECG signal obtained by the ANNE Chest sensor is not intended for manual discrimination of any arrhythmias or cardiac conditions.

AI/ML Overview

The provided document, primarily an FDA 510(k) clearance letter and summary, details the "ANNE Chest" device and its substantial equivalence to predicate devices. It includes performance data, but it does not contain the level of detail typically found in a comprehensive clinical study report for evaluating acceptance criteria and proving device performance for areas like AI/ML algorithms.

Specifically, the document lacks the following information crucial for a detailed response on acceptance criteria and study proving device meets them for AI/ML components:

Explicit Acceptance Criteria Tables: While performance specifications are listed for heart rate, respiratory rate, and skin temperature, these are not presented as explicit "acceptance criteria" against which the device passed.
Detailed Study Design for each feature: Only a brief summary of a clinical validation study for respiratory rate accuracy is provided. Details on ECG waveform analysis, activity, fall detection, and body position, if they incorporate AI/ML, are not detailed in terms of their dedicated performance studies.
Sample Size for Test Set and Data Provenance for all features: Only n=40 is mentioned for respiratory rate. Data provenance (country, retrospective/prospective) is not specified.
Expert Ground Truth Details: The number and qualifications of experts for establishing ground truth are not mentioned for any of the features.
Adjudication Method: No information on adjudication is provided.
MRMC Study Details: No information on multi-reader multi-case studies or effect sizes of human reader improvement with AI assistance is provided.
Standalone AI Performance: The document describes the device as a sensor measuring physiological signals. It mentions software for display, storage, and analysis, but doesn't explicitly refer to AI/ML algorithms that operate in a "standalone" fashion where their performance metrics (e.g., sensitivity, specificity, AUC) against a ground truth would be relevant. The respiratory rate accuracy is presented as a direct comparison to a reference device.
Ground Truth Type for all features: Only "End Tidal Carbon Dioxide (EtCO2) monitor reference" is mentioned for respiratory rate.
Training Set Sample Size and Ground Truth Establishment: No information about training sets or how their ground truth was established is provided, suggesting that the device's functions might rely more on signal processing rather than intricate AI/ML models requiring large training datasets with defined ground truth methods.

Based on the limited information provided in the document, here's what can be extracted and inferred:

Acceptance Criteria and Reported Device Performance

The document provides performance specifications for certain physiological measurements. While not explicitly stated as "acceptance criteria," these are the performance targets the device claims to meet.

Table 1: Reported Device Performance

Parameter	Acceptance Criteria / Specification	Reported Device Performance (from text)
Heart Rate	30 - 270 bpm	(the greater of ±10% or ±5bpm)
Respiratory Rate	8 - 35 bpm	Mean absolute error (MAE) of 1.27 breaths per minute (against capnography reference) at 8, 13, 23, 27, and 35 bpm. (±3 bpm RMSE)
Skin Temperature	73.4°F - 109.4°F (23°C - 43°C)	±0.54°F (±0.3°C)
Activity	(Not specified)	Accelerometer-based
Body Position	(Not specified)	Body Position
Fall Detection	(Not specified)	Sensor collects 3-axis accelerometry
ECG Waveform	Compliant to IEC standards	Compliant to IEC 60601-2-27 and IEC 60601-2-47
ECG Sampling Freq.	(Not specified)	512 Hz
ECG Streaming Freq.	(Not specified)	256 Hz
ECG Resolution	(Not specified)	18 bit

Note: The document explicitly states: "The ECG signal obtained by the ANNE Chest sensor is not intended for manual discrimination of any arrhythmias or cardiac conditions." This suggests the ECG waveform is for general display and rate calculation, not for specific diagnostic interpretation that might involve AI/ML for abnormality detection.

Study Details Proving Device Meets Acceptance Criteria

1. Sample Size for Test Set and Data Provenance:
* Respiratory Rate: n=40 healthy adult and adolescent subjects.
* Data Provenance: Not specified (e.g., country of origin). The study is described as "a clinical validation study," implying it was prospective for this evaluation.
* Other features (ECG, Heart Rate, Skin Temperature, Activity, Fall Detection, Body Position): No specific sample sizes for clinical validation studies are mentioned, only adherence to standards (e.g., IEC 60601-2-27, IEC 60601-2-47 for ECG) and "performance testing." This suggests these features might have been validated through bench testing or engineering verification rather than clinical studies of the type described for respiratory rate.

2. Number of Experts used to establish Ground Truth and Qualifications:
* Not specified. The ground truth for respiratory rate was an "End Tidal Carbon Dioxide (EtCO2) monitor reference," which is an objective measurement, not expert consensus. For other features, no details about expert involvement for ground truth are provided.

3. Adjudication Method for the Test Set:
* None specified. Given the use of an objective reference device (EtCO2 monitor) for respiratory rate, human adjudication would not be applicable for this specific metric.

4. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
* No. The document does not describe any MRMC studies or human reader improvement with AI assistance. The device focuses on physiological measurements rather than interpretive tasks for human readers.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
* Implied for Respiratory Rate accuracy. The study directly compared the ANNE Chest sensor's respiratory rate measurement against a capnography reference, which aligns with standalone performance evaluation for that specific function. For other parameters like heart rate and skin temperature, this is also implied through performance specifications. The device itself is a measurement tool, outputs direct physiological values, and does not describe AI intended for interpretation or decision support that would typically have a human-in-the-loop component.

6. The Type of Ground Truth Used:
* Respiratory Rate: Objective reference standard: "End Tidal Carbon Dioxide (EtCO2) monitor reference."
* Other features: Not explicitly stated, but likely objective measurements from reference devices/standards (e.g., test ECG signals for ECG compliance, calibrated thermometers for skin temperature).

7. The Sample Size for the Training Set:
* Not specified. The document does not indicate the use of machine learning models that would require a distinct training set. The descriptions of the device functions point towards signal processing and known algorithms for extracting vital signs from raw sensor data, rather than complex AI requiring large, labeled training datasets.

8. How the Ground Truth for the Training Set was Established:
* Not applicable based on available information. Since no training set or complex AI model development requiring one is mentioned, this information is not provided.

Summary

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June 3, 2024

Sibel Health Inc. Sarah Coughlin Regulatory Affairs Manager 2017 N Mendell Unit 2SE Chicago, Illinois 60614

Re: K240251

Trade/Device Name: ANNE Chest Regulation Number: 21 CFR 870.2910 Regulation Name: Radiofrequency Physiological Signal Transmitter And Receiver Regulatory Class: Class II Product Code: DRG, FLL, MWJ, KMI, BZQ, MWI Dated: May 10, 2024 Received: May 10, 2024

Dear Sarah Coughlin:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Jennifer W. Shih -S

Jennifer Shih Kozen 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

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Indications for Use

Submission Number (if known)

K240251

Device Name

ANNE Chest

Indications for Use (Describe)

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

-Submitter:

Sibel Health Inc. 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859

Official Correspondent: Sarah Coughlin, Regulatory Affairs Manager 2017 N Mendell St. Suite 2SE Chicago, IL 60614 Tel: (224) 251-8859

Date Prepared: 05/09/2024

. Device Information

Name of Device: ANNE Chest 510K Number: K240251 Classification Name: Radiofrequency Physiological Signal Transmitter and Receiver Regulation: 21 CFR §870.2910 Regulatory Class: Class II Product Classification Code: DRG, FLL, MWJ, KMI, BZQ, MWI

lll. Predicate Device

Primary Predicate Trade Name: ANNE One 510(k): K223711 Device Manufacturer: Sibel Health Inc.

Secondary Predicate

Trade Name: Portrait Mobile Monitoring Solution 510(k) Number: K230626 Manufacturer: GE Medical Systems Information Technologies, Inc.

IV. Device Description

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obtained by the ANNE Chest sensor is not intended for manual discrimination of any arrhythmias or cardiac conditions.

V. Indications for Use

The ANNE Chest is a wearable, wireless sensor intended for the measurement of electrocardiography (ECG) waveforms, heart rate, respiratory rate, activity, fall detection, body position, and skin temperature. The ANNE Chest sensor is not intended to monitor or measure respiratory rate while the patient undergoes significant motion or is active. The ANNE Chest sensor communicates with compatible software applications for the display, storage, and analysis of data. The device is intended to provide continuous physiological information as an aid to diagnosis and treatment by healthcare professionals in general care patients who are 12 years of age or older in clinical and home environments. The device is not intended for use on critical care patients.

VI. Performance Data

The following consensus standards and bench testing were used to evaluate the substantial equivalence of ANNE Chest:

Electrical safety and electromagnetic compatibility testing according to ANSI/AAMI . ES60601-1:2005/(R) 2020 and IEC 60601-1-2:2014 standards. Electrical safety testing in the home healthcare environment per IEC 60601-1-11:2015.
Biocompatibility testing according to ISO 10993-5:2009, ISO 10993-10:2021, and ISO 10993-23:2021 for patient contacting materials.
Wireless coexistence testing according to ANSI IEEE C63.27-2017.
. Software verification and validation testing according to IEC 62304:2015 and the FDA guidance document, Content of Premarket Submissions for Software Contained in Medical Devices.
Safety and performance testing of ECG per IEC 60601-2-27:2011 and IEC . 60601-2-47:2012.
. Defibrillation testing according to Section 8.5.5 of ANSI/AAMI ES60601-1:2005/(R)2012
Shelf life testing of the adhesive to demonstrate performance over the intended device life cycle.
Bench testing to demonstrate the mechanical durability of the sensors.
Usability testing in accordance with the FDA guidance document, Applying Human Factors and Usability Engineering to Medical Devices.
Performance testing of heart rate, respiratory rate, skin temperature, activity, and posture. ●
Cybersecurity evaluation according to the FDA guidance document, Cybersecurity in ● Medical Devices: Quality System Considerations and Content of Premarket Submissions

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VII. Clinical Studies

Respiratory Rate Accuracy: A clinical validation study was conducted in n=40 healthy adult and adolescent subjects to evaluate respiratory rate measurements with the ANNE Chest sensor against an End Tidal Carbon Dioxide (EtCO2) monitor reference. Testing encompassed a range of patient demographics including age, gender, and BMI. Participants were asked to breathe along with a metronome at 8, 13, 23, 27, and 35 breaths per minute. The test also evaluated respiratory rate at different body positions and after motion activities. The mean absolute error (MAE) between the ANNE Chest sensor and capnography was 1.27 breaths per minute.

VIII. Conclusion

The results of the substantial equivalence assessment, taken together with safety and performance testing data, demonstrate that ANNE Chest's performance characteristics are substantially equivalent to the predicate device in both technology and intended use.

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	Subject deviceSibel Health Inc.	Primary Predicate deviceSibel Health Inc.	Secondary PredicateGE Medical SystemsInformationTechnologies, Inc.	Variances / Equivalence
TradeName	ANNE Chest	ANNE One	Portrait Mobile MonitoringSolution
510(k)Number	K240251	K223711	K230626
Class	II	II	II	Equivalent
ProductCode	DRG, FLL, KMI, MWJ,BZQ, MWI	DRG, MWI, FLL, DQA,MWJ, KMI	MHX, MSX, DRG, BZQ,DQA	EquivalentBZQ is a product code inthe subject device thatwas not present in thepredicate device.However, the predicatedevice did monitorbreathing frequency. TheK230626 secondarypredicate is used tosupport the BZQ productcode.
RegulationNumberandRegulationName	870.2910Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	870.2910Transmitters andReceivers, PhysiologicalSignal, Radiofrequency	870.1025Arrhythmia Detector andAlarm (IncludingST-Segment Measurementand Alarm)	Equivalent
Indicationsfor Use	The ANNE Chest is awearable, wireless sensorintended for themeasurement ofelectrocardiography (ECG)waveforms, heart rate,respiratory rate, activity,fall detection, bodyposition, and skintemperature. The ANNEChest sensor is notintended to monitor ormeasure respiratory ratewhile the patientundergoes significantmotion or is active. TheANNE Chest sensorcommunicates withcompatible softwareapplications for the display.storage, and analysis ofdata. The device isintended to providecontinuous physiologicalinformation as an aid todiagnosis and treatment	ANNE One is a wirelessmonitoring platformindicated for themeasurement ofelectrocardiography (ECG)waveforms, heart rate,respiratory rate, functionaloxygen saturation ofarterial hemoglobin(SpO2), pulse rate, activity,body position, falldetection, skintemperature, and bodytemperature by qualifiedhealthcare professionals inhome and healthcaresettings. ANNE One iscompatible with third-party,FDA-cleared devices fornoninvasive bloodpressure, SpO2, pulserate, and bodytemperaturemeasurements. Thedevice is indicated formonitoring ECG	Portrait Mobile MonitoringSolution: The PortraitMobile Monitoring Solutionis intended to acquire,store, calculate, displayand export patientmonitoring data as well asprovide real time alarmingfor monitoring adult andpediatric patients (3 yearsof age and older, andweighing more than 10kg).Physiological parametersand waveforms supportedare:• Pulse oximetry(SpO2/pulse rate)• Respiration rate (RR)Continuous pulse oximetryand respiration ratemonitoring may be usedfor patients at risk of	SimilarThe subject device utilizesthe same ANNE Chestsensor for the monitoringof ECG, heart rate,respiratory rate, bodyposition, activity, and skintemperature as thepredicate device ANNEOne. The ANNE Onepredicate has additionaloutputs including SpO2,pulse rate, bodytemperature, andnon-invasive bloodpressure. This differencedoes not affect safety oreffectiveness of the outputparameters indicated foruse in the subject device.

		by healthcareprofessionals in generalcare patients who are 12years of age or older inclinical and homeenvironments. The deviceis not intended for use oncritical care patients.	waveforms and heart rateon ambulatory patients.The device is not intendedto monitor or measurerespiratory rate, SpO2,pulse rate, or noninvasiveblood pressure while thepatient undergoessignificant motion or isactive.ANNE One continuouslymonitors the orientation ofpatients to aid in theprevention of pressureulcers for at-risk patients.The system providesvisual notification when thepatient's position has notchanged from a presetthreshold of time.The device is intended foruse on general carepatients who are 12 yearsof age or older as ageneral patient monitor toprovide continuousphysiological informationas an aid to diagnosis andtreatment. The data fromANNE One are transmittedwirelessly for display,storage, and analysis. Thedevice is not intended foruse on critical carepatients.	cardiorespiratory andinfectious complications.The Portrait MobileMonitoring Solution isintended for use under thedirect supervision of alicensed practitioner, or bypersonnel trained in properuse of the equipment in aprofessional healthcarefacility.This device is not anApnea monitor (i.e., do notrely on the device fordetection or alarm for thecessation of breathing).This device should not beused for lifesustaining/supportingpurposes. The PortraitMobile Monitoring Solutionis not intended for use in acontrolled MagneticResonance (MR)environment.
	TargetPopulation	12 years of age and older	12 years of age and older	3 years of age and older,weighing more than 10 kg	Equivalent
	UseEnvironment	Home and healthcaresettings	Home and healthcaresettings	Professional healthcarefacility	Equivalent
	Reprocessing	Multiple patient reusable	Single patient reusable	Semi-disposable	DifferentThe subject device isreusable on multiplepatients. Validation of thecleaning process andmechanical testingdemonstrate that thisdifference does not impactsafety or effectiveness.
	SensorPlacement	Chest	Finger and Chest	Portrait WearableRespiration Rate Sensorand Portrait RR ElectrodePatch:	EquivalentPlacement location of theANNE Chest sensor is thesame between the subject
			Chest	and predicate devices.The predicate deviceincludes an additionalsensor, the ANNE LimbSensor, that is worn on thefinger. The ANNE LimbSensor is not part of thescope of the subjectdevice.
Heart Rate	30 - 270 bpm(the greater of ±10% or±5bpm)	30-270 bpm(the greater of ± 10% or ±5 bpm)	N/A	Equivalent
RespiratoryRate	Accelerometer and ECGderived8 - 35 bpm (±3 bpmRMSE)	Accelerometer-derived8 - 30 bpm (± 3 bpmRMSE)	Derived from impedanceand biopotential signalsAccuracy range from 4 to60 breaths/minute (± 3bpm RMSE)	SimilarThe range for respiratoryrate has been extended inthe subject device from theK223711 predicate. Therange is less than theK230626 secondarypredicate. Respiratory rateover the output range forthe subject device meetsthe same accuracyspecification as bothpredicates.
SkinTemperature	73.4°F - 109.4°F (±0.54°F)23°C - 43°C (±0.3°C)	73.4°F - 109.4°F (±0.54°F)23°C - 43°C (±0.3°C)	N/A	Equivalent
BodyTemperature	Not Applicable	± 0.05 °C ( ± 0.1 °F )during 35.00 °C ~38.00°C(95.00 °F ~100.40°F) ±0.1°C ( ± 0.2 °F ) duringT<35.00°C (95.00°F) orT>38.00°C (100.40°F)with use of an optionalcompatible thermometer	N/A	DifferentThe subject device doesnot have body temperaturefunctionality.
SpO2	Not Applicable	ARMS ≤ 3% (range70-100%)	ARMS ≤ 2% (range70-100%)Low perfusion: ARMS ≤ 3%With motion: ARMS ≤ 3%	DifferentThe subject device doesnot have SpO2functionality.
Pulse Rate	Not Applicable	30-300 bpm(the greater of ± 10% or ±5 bpm)	30-250 bpm≤ 2bpm (30 to 250 bpm)With motion: ≤5bpm	DifferentThe subject device doesnot have pulse ratefunctionality.
Activity	Accelerometer	Accelerometer	N/A	Equivalent
Posture	Body Position	Body Position	N/A	Equivalent
Non-Invasive BloodPressure	Not Applicable	0 - 300 mmHg (± 3 mmHg)	N/A	Not Applicable
(NIBP)		with use of an optionalcompatible blood pressurecuff		The subject device doesnot have NIBPfunctionality.
ECGWaveform	Compliant to IEC60601-2-27Compliant to IEC60601-2-47	Compliant to IEC60601-2-27Compliant to IEC60601-2-47	N/A	Equivalent
ECGSamplingFrequency	ECG Sampling Frequency:512 HzStreaming Frequency: 256Hz	ECG Sampling Frequency:512 HzStreaming Frequency: 256Hz	N/A	Equivalent
ECGResolution	18 bit	18 bit	N/A	Equivalent
Data	Data is transmittedwirelessly via Bluetoothfrom the sensor to theSibel SDK, which may beintegrated within softwareapplications for the displayand storage of data.	Data is transmittedwirelessly via Bluetoothfrom the sensors to amobile device. Data maybe downloaded for laterstorage and analysis.	Data is transmittedwirelessly from the PortraitSensor Battery to thePortrait Mobile PatientMonitor over a wirelessMedical Body AreaNetwork (MBAN) using aproprietary protocol.	SimilarThe subject device allowscommunication withcompatible softwareapplications for the display,storage, and analysis ofdata.
Notification	No notification ability.	Provides visual notificationon patient orientation.	Real time alarming	SimilarThe subject deviceprovides a visualnotification on patientorientation.
Motion	Respiratory ratemeasurements should notbe taken during motion.Heart rate and ECG maybe taken during motion.	Respiratory rate, SpO2,and pulse ratemeasurements should notbe taken during motion.Heart rate and ECG maybe taken during motion.	Ambulatory monitoring	EquivalentEquivalent for applicableparameters
Measurement modality	Continuous measurements	Continuous measurements	Continuous measurements	Equivalent
Monitoringtype	Real time monitoring	Real time monitoringData storage for lateranalysis	Real time monitoring	Equivalent
ApneaClaims	Not an apnea alarm	Not an apnea alarm	Not an apnea alarm	Equivalent

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Regulation Number and Section

§ 870.2910 Radiofrequency physiological signal transmitter and receiver.

(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).