M Series Patient Monitor is intended to be used for monitoring, displaying, storing and alarming of multiple physiological parameters including ECG, Heart Rate (HR). Respiration Rate (RESP), Pulse Oxygen Saturation (SpO2), Pulse Rate (PR), Non-invasive Blood Pressure (NIBP), Invasive Blood Pressure (IBP), carbon dioxide (CO2), and Temperature (TEMP) of adult, pediatric and neonatal patient.

The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians. It is not intended for helicopter transport or hospital ambulance.

Note: M7000 does not have functions of Invasive Blood Pressure and Carbon Dioxide.

Device Description

The proposed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000, are modification devices to the existed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000 as cleared in K100046 at 04/08/2010.

The proposed devices and the existed devices share same intended use, design principle and technical specifications. The main modification of the proposed devices is adding a SpO2 module, which was designed and manufactured by Masimo Corporation and previously cleared by FDA in K053269 at 12/21/2005. It is an independent module installed within the patient monitor, without any other modifications, and shall be used with the specified accessories, which are listed in following table.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the M Series Patient Monitor (K131876).

Overview:

This 510(k) submission is for modifications to an existing M Series Patient Monitor (K100046). The primary modification is the inclusion of a Masimo SpO2 module, which itself was previously cleared by the FDA (K053269). Therefore, the provided information focuses on demonstrating that the integrated device meets safety and performance standards, particularly for the SpO2 function, and is substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily compares the proposed device's performance characteristics to the predicate device (K100046) and the standalone Masimo SpO2 module (K053269) rather than explicitly stating "acceptance criteria" in a separate section with specific numerical targets. However, the implicit acceptance criterion is that the proposed device performs at least as well as or identically to the predicate devices for each physiological parameter.

Below are the performance characteristics presented as a comparison, where "Same" indicates the proposed device meets the predicate's specification, and the specific numbers represent the reported performance for the proposed device (which is equivalent to the predicate).

Parameter	Acceptance Criteria (Predicate / Masimo SpO2 Module Specification)	Reported Device Performance (Proposed Device)
ECG
Lead Mode	5-leads ECG input / 3-leads ECG input	Same
CMRR	MON ≥105dB / OPS ≥105dB	Same
Sweep speed	12.5mm/s, 25mm/s, 50mm/s	Same
HR Range	10~350 bpm	Same
HR Accuracy	±1% or ±1 bpm, whichever is greater	Same
NIBP
Method	Oscillometric	Same
Measurement Unit	mmHg / kPa	Same
Measurement Range	Adult 10-270 mmHg, Pediatric 10-235 mmHg, Neonatal 10-135 mmHg	Same
Accuracy (Static)	±2% or ±3 mmHg, whichever is greater	Same
Accuracy (Clinical)	±5 mmHg average error, ≤ 8 mmHg standard deviation	Same
TEMP
Range	0.0~50.0°C	Same
Accuracy	At 45.1°C~~50.0°C, ±0.2°C; At 25.0°C~~45.0°C, ±0.1°C; At 0.0°C~24.9°C, ±0.2°C (exclusive of probe)	Same
RESP
Method	Impedance variation between RA-LL (R-F)	Same
Measurement Range	0~150 rpm	Same
Accuracy	±2 rpm	Same
BLT SpO2 Module		(This refers to the previous SpO2 module in K100046, not the new Masimo module)
SpO2 Range	0~100%	Same
SpO2 Accuracy	At 70~~100%, ±2%; At 0~~69%, unspecified	Same
PR Range	25~250 bpm	Same
PR Accuracy	±1% or ±1 bpm, whichever is greater	Same
Masimo SpO2 Module (Proposed Device/K053269 Predicate)
SpO2 Range	1~100%	1~100% (Same as Masimo predicate K053269)
SpO2 Accuracy	At 70~~100%: ±2% (adult/pediatric, non-motion); At 70~~100%: ±3% (neonate, non-motion); At 70~~100%: ±3% (motion conditions); At 0~~69%, unspecified	At 70~~100%: ±2% (adult/pediatric, non-motion conditions); At 70~~100%: ±3% (neonate, non-motion conditions); At 70~~100%: ±3% (motion conditions); At 0~~69%, unspecified (Same as Masimo predicate K053269)
PR Range	25~240 bpm	25~240 bpm (Same as Masimo predicate K053269)
PR Accuracy	±3 bpm (non-motion conditions); ±5 bpm (motion conditions)	±3 bpm (non-motion conditions); ±5 bpm (motion conditions) (Same as Masimo predicate K053269)
PI Range	0.02 ~ 20.0%	0.02 ~ 20.0% (Same as Masimo predicate K053269)
IBP (Inapplicable to M7000)
Measurement Range	-50 ~ +300 mmHg	Same
Sensitivity	5uV/V/mmHg, 2%	Same
Accuracy	±4mmHg or 4%, whichever is greater	Same
EtCO2 (Inapplicable to M7000)	(This refers to the previous EtCO2 module in K100046, which is still used)
Method	Infrared Absorption	Same
Mode	Main Stream / Side Stream	Same
Measurement Range	0~~19.7 %(0~~150 mmHg)	Same
Accuracy	0~~40 mmHg, ±2 mmHg; 41~~70 mmHg, ±5% of reading; 71~~100 mmHg, ±8% of reading; 101~~150 mmHg, ±10% of reading	Same

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

The document does not explicitly state the sample size used for the clinical or non-clinical test set. It mentions that "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

For the Masimo SpO2 module, the text states its accuracy has been "verified comply with the declaration of specification" and refers to its prior clearance (K053269). This suggests that the clinical data supporting the SpO2 performance would have been part of the K053269 submission, not newly generated for K131876. Therefore, the provenance of that data would be from the original Masimo clearance study. The K131876 submission itself primarily relies on equivalence to the previously cleared Masimo module and adherence to standards.

No details are provided regarding the country of origin of the data or whether it was retrospective or prospective.

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

This information is not provided in the given text. For a device like a patient monitor, ground truth for physiological parameters is typically established through recognized calibrated reference devices or invasive measurements, rather than expert consensus on interpretation. For SpO2, this would involve co-oximetry and controlled hypoxia studies. Since this submission relies on equivalence to a previously cleared module, the details of how ground truth was established would reside in the original Masimo K053269 submission.

4. Adjudication Method for the Test Set

This information is not provided. Given the nature of a patient monitor measuring physiological parameters, "adjudication" in the sense of multiple experts reviewing an output is less applicable than direct comparison against a known reference standard (gold standard).

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

A MRMC comparative effectiveness study was not performed, nor is it applicable to this type of device. MRMC studies are typically used for diagnostic devices where human interpretation (readers) of images or data is a critical component, and the AI's role is to assist or replace that interpretation. This patient monitor provides direct physiological measurements.

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

The entire device (including the Masimo SpO2 module) functions as a standalone measurement device. Its performance, as specified in the tables (e.g., SpO2 accuracy, PR accuracy), is its standalone algorithm-only performance. The "human-in-the-loop" aspect is the clinician interpreting and acting upon the displayed physiological data, but the measurement itself is autonomous. The verification of compliance with specifications effectively serves as the standalone performance study.

7. Type of Ground Truth Used

For patient monitors measuring vital signs, the ground truth is typically established using:

Calibrated Reference Devices: For parameters like NIBP, temperature, and respiration, highly accurate, independently calibrated devices serve as the reference.
Invasive Measurements (Gold Standard): For SpO2, the gold standard for accuracy verification involves controlled desaturation studies where arterial blood samples are taken and analyzed by a co-oximeter. This likely formed the basis for the Masimo SpO2 module's original clearance (K053269).
Physiological Stimuli: For ECG, a calibrated ECG simulator is used.

The document implicitly refers to these types of ground truth by mentioning compliance with standards like ISO 9919:2005 for pulse oximeters, which mandates specific testing methodologies against reference standards.

8. Sample Size for the Training Set

The document does not report a sample size for a training set. This is because the device is a measurement instrument incorporating a previously cleared, established Masimo SpO2 module. While the Masimo module itself would have been developed using some form of training data (e.g., spectral data to train its algorithms to differentiate oxygenated from deoxygenated blood and motion artifacts), this detail is not provided in a 510(k) summary for a subsequent device integrating it. The focus of this K131876 submission is on integrating the module and ensuring overall device safety and performance according to relevant standards.

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

As no training set is discussed or implied for the M Series Patient Monitor itself in this submission, this information is not provided. The embedded Masimo SpO2 module's original development would have involved establishing ground truth for its algorithms, likely through clinical trials with subjects experiencing varying levels of oxygen saturation, with reference measurements from co-oximeters.

Summary

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510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K131876

l. Date of Submission: 06/08/2013

Sponsor Identification

Guangdong Biolight Meditech Co., Ltd. No.2 Innovation First Road, Technical Innovation Coast, Hi-tech Zone, Zhuhai, P.R. China

Establishment Registration Number: 3007305624

Contact Person: Jin Liang Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang j@blt.com.cn

Submission Correspondent 3.

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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4. Proposed Device Identification

Proposed Device Name: M Series Patient Monitor Proposed Device Model: M66, M69, M7000. M8000 and M9000 Proposed Device Common Name: Patient Monitor

Regulatory Information:

Classification Name: Monitor, Physiological, Patient;

Classification: II:

Product Code: MHX:

Regulation Number: 21 CFR 870.1025;

Review Panel: Cardiovascular;

Subsequent Product Code:

ProductCode	RegulationNumber	Classification Name	Panel
DRT	870.2300	Monitor, Cardiac (incl. cardiotachometer & rate alarm)	Cardiovascular
DXN	870.1130	System, Measurement, Blood-pressure, Non-invasive	Cardiovascular
DSK	870.1110	Computer, Blood-pressure	Cardiovascular
DQA	870.2700	Oximeter	Anesthesiology
BZQ	868.2375	Monitor, Breathing Frequency	Anesthesiology
CCK	868.1400	Analyzer, Gas, Carbon-Dioxide, Gaseous-phase	Anesthesiology
FLL	880.2910	Thermometer, Electronic, Clinical	General Hospital

Intended Use Statement:

Note: M7000 does not have functions of Invasive Blood Pressure and Carbon Dioxide.

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Predicate Device Identification 5.
510(k) Number: K100046 Product Name: M Series Patient Monitor Manufacturer: Guangdong Biolight Meditech Co., Ltd.

510(k) Number: K053269 Product Name: MASIMO SET RAD-8 PULSE OXIMETER Manufacturer: Masimo Corporation

1. Device Description
  The proposed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000, are modification devices to the existed devices, M Series Patient Monitors, M66, M69, M7000, M8000 and M9000 as cleared in K100046 at 04/08/2010.

ITEM	Accessory	Reusable/Disposable	Population	Type
DCI / 2501	SpO2 Sensor	Reusable	Adult	Clip
DCIP / 2502	SpO2 Sensor	Reusable	Pediatric	Clip
Neo / 2514	SpO2 Sensor	Disposable	Infant	Wrap
M-LNC1 / 2523	Extension Cable	N.A.	N.A.	N.A.

Table 3-1 Accessories of Masimo SpO2 Module

7. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ISO 14971:2007 Medical devices -- Application of risk management to medical devices; IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995;

IEC 60601-1-2, (Edition 2:2001 with Amendment 1:2004), Medical Electrical Equipment - Part 1-2:

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General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility -- Requirements and Tests:

ISO 9919:2005: Medical electrical equipment - Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use.

Substantially Equivalent (SE) Conclusion 8.

The following table compares the DEVICE to the predicate device with respect to intended use. technological characteristics and principles of operation, etc.

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	Item	Proposed Devices	Predicate Device
	Product Code	M Series Patient Monitor	K100046
		MHX	Same
	Regulation No.	21 CFR 870.1025	Same
	Class	Class II	Same
	Intended Use	M Series Patient Monitor is intended to be used formonitoring, displaying, reviewing, storing andalarming of multiple physiological parametersincluding ECG. Heart Rate (HR). Respiration Rate(RESP). Pulse Oxygen Saturation (SpO2), Pulse Rate(PR), Non-invasive Blood Pressure (NIBP), InvasiveBlood Pressure (IBP), carbon dioxide (CO2), andTemperature (TEMP) of adult, pediatric and neonatalpatient.The monitor is to be used in healthcare facilities byclinical physicians or appropriate medical staff underthe direction of physicians. It is not intended forhelicopter transport or hospital ambulance.Note: M7000 does not have functions of InvasiveBlood Pressure and Carbon Dioxide	Same
Feature	Display	Colour TFT	Same
	Alarm	Visual and audio alarming	Same
	Electrical Safety	The proposed devices were tested to demonstrate tocomply with IEC 60601-1.	Same
	EMC	The proposed devices were tested to demonstrate tocomply with IEC 60601-1-2	Same
	Patient-contactMaterial	ECG Electrode: Conductive adhesiveSpO2 Sensor: SiliconeNIBP Cuff: Polyester fibreEtCO2 Sensor: PVCTemperature Probe: PVC	Same
	Level of Concern ofthe Software	Major	Same
	Label and Labeling	Conforms to FDA Regulatory Requirements	Same
Item	Proposed Devices	Predicate Devices
	M Series Patient Monitor	K100046
ECG Lead Mode	5-leads ECG input / 3-leads ECG input	Same
ECG CMRR	MON ≥105dB / OPS ≥105dB	Same
ECG Sweep speed	12.5mm/s. 25mm/s. 50mm/s	Same
HR Range	10~350 bpm	Same
HR Accuracy	±1% or ±1 bpm, whichever is greater	Same
NIBP Method	Oscillometric	Same
NIBP Measurement Unit	mmHg / kPa	Same
NIBP	Adult 10-270 mmHg	Same
Measurement	Pediatric 10-235 mmHg	Same
Range	Neonatal 10-135 mmHg	Same
	(Static) ±2% or ±3 mmHg. whichever is greater	Same
NIBP Accuracy	(Clinical) ±5 mmHg average error≤ 8 mmHg standard deviation
TEMP Range	0.0~50.0°C	Same
TEMP Accuracy	At 45.1°C~~50.0°C, ±0.2°C (exclusive of probe)At 25.0°C~~45.0°C, ±0.1°C (exclusive of probe)At 0.0°C~24.9°C, ±0.2°C (exclusive of probe)	Same
RESP Method	Impedance variation between RA-LL (R-F)	Same
RESP Measurement Range	0~150 rpm	Same
RESP Accuracy	±2 rpm	Same
BLT SpO2 Module
SpO2 Range	0~100%	Same
SpO2 Accuracy	At 70~~100%, ±2%At 0~~69%, unspecified	Same
PR Range	25~250 bpm	Same
PR Accuracy	±1% or ±1 bpm,whichever is greater	Same
Necllor SpO2 Module
SpO2 Range	1~100%	Same
SpO2 Accuracy	At 70~~100%, ±2 digits (Adult)At 70~~100%, ±3 digits (Neonate)At 70~~100%, ±2 digits (Low Perfusion)At 0~~69%, unspecified	Same
PR Range	20~250 bpm	Same
PR Accuracy	±3 digits	Same

Table 3-2 Comparison of General and Safety Characteristics

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Table 3-3 Comparison of ECG, NIBP, TEMP, RESP and SpO2 Characteristics

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Item	Proposed Devices	PredicateDevicesK053269	PredicateDevicesK100046
SpO2 Module	MASIMO Module	Same	Similar
SpO2 Range	1~100%	Same	Same
SpO2Accuracy	At 70~~100%: $\pm$ 2% (adult/pediatric, non-motionconditions)At 70 ~ 100%: $\pm$ 3% (neonate, non-motionconditions)At 70~~100%: $\pm$ 3% (motion conditions)At 0~69%, unspecified	Same	Similar
PR Range	25~240 bpm	Same	Similar
PR Accuracy	$\pm$ 3 bpm (non-motion conditions)$\pm$ 5 bpm (motion conditions)	Same	Similar
PI Range	0.02 ~ 20.0%	Same	NA

Table 3-4 Comparison of Masimo SpO2 Characteristics

Table 3-5 Comparison of IBP and EtCO2 Characteristics (Inapplicable to M7000)

Item	Proposed Devices	Predicate Devices
	M Series Patient Monitor	K100046
IBP Measurement Range	-50 ~ +300 mmHg	Same
IBP Sensitivity of transducer	5uV/V/mmHg, 2%	Same
IBP Accuracy	$\pm$ 4mmHg or 4%, whichever is greater	Same
EtCO2 Method	Infrared Absorption	Same
EtCO2 Mode	Main Stream / Side Stream	Same
EtCO₂ Measurement Range	0~~19.7 %(0~~150 mmHg)	Same
EtCO2 Accuracy	0 ~ 40 mmHg, $\pm$ 2 mmHg41 ~ 70 mmHg, $\pm$ 5% of reading71 ~100 mmHg, $\pm$ 8% of reading101 ~ 150 mmHg, $\pm$ 10% of reading	Same

The proposed device has a Masimo SpO2 Module, while the predicate device M Series Patient Monitor (K100046) docsn't have. The Masimo SpO2 Module was designed and manufactured by Masimo Corporation and previously cleared by FDA in K053269. And Sp02 and pulse rate accuracy of the proposed device with Masimo SpO2 Module has been verified comply with the declaration of specification. Therefore, the difference will not affectiveness of the proposed device.

The proposed devices, M Series Patient Monitors, are determined to be Substantially Equivalent (SE) to the predicate devices, M Series Patient Monitors (K 100046), in respect of safety and effectiveness.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/7/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission of providing health and human services to the nation. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

February 27, 2014

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Guangdong Biolight Meditech Co. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K131876

Trade/Device Name: M Series Patient Monitor models M66, M69, M7000, M8000, and M9000 Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Monitor Regulatory Class: Class II Product Code: MHX Dated: January 29, 2014 Received: January 30, 2014

Dear Ms. Diana Hong:

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. 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 801); medical device reporting (reporting of medical

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Page 2 - Ms. Diana Hong

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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

Enclosure

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Indications for Use

510(k) Number: K131876 Device Name: M Series Patient Monitor

Indications for Use:

M Series Patient Monitor is intended to be used for monitoring, reviewing, storing and alarming of multiple physiological parameters of adult, pediatric and neonatal patient as listed below:

Parameters	M66	M69	M7000	M8000	M9000
ECG	x	x	x	x	x
Heart Rate	x	x	x	x	x
Respiration Rate (RESP)	x	x	x	x	x
Pulse Oxygen Saturation (SpO2)	x	x	x	x	x
Non-Invasive Blood Pressure (NIBP)	x	x	x	x	x
Invasive Blood Pressure (IBP)	x	x	--	x	x
Carbon Dioxide (CO2)	x	x	--	x	x
Temperature (TEMP)	x	x	x	x	x

The monitor is to be used in healthcare facilities by clinical physicians or appropriate medical staff under the direction of physicians.

It is not intended for helicopter transport or hospital ambulance.

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OOVER-THE-COUNTER USE (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

am D. Zuckerman - S Page 1 of 1
2014.02.27 08:40:56 -05'00' 2-1

2-1

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.