K Number

Device Name

PULSE OXIMETER

Manufacturer

HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD.

Date Cleared

2014-12-04

(219 days)

Product Code

DQA DOA

Regulation Number

870.2700

Intended Use

The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals.

Device Description

The proposed devices of Pulse Oximeter FS10A, FS20A are fingertip devices, which can display SpO2 and pulse rate value. The proposed devices consist of detector and emitter LED, CPU, display unit and power unit. The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 906nm, which is infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light overtime. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds. The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization. The devices are for prescription. The devices do not contain drug or biological products. The Pulse Oximeters FS10A,FS20A share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Pulse Oximeters FS10A, FS20A are the same. The devices are software-driven and the software validation is provided in Section of Software.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K139047

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard pulse oximetry measurement principle based on light absorption and a CPU for processing, with no mention of AI or ML algorithms.

Therapeutic

No.
The device is intended for "spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate," which are diagnostic measurements, not therapeutic interventions.

Diagnostic

Yes

The device measures physiological parameters (SpO2 and pulse rate) which are used for monitoring a patient's health status, thus aiding in assessment and potential diagnosis.

SaMD (Software as a Medical Device)

The device description explicitly states it consists of hardware components such as a detector and emitter LED, CPU, display unit, and power unit, and is a fingertip device. While it is software-driven, it is not solely software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
Device Function: The Pulse Oximeter FS10A and FS20A are non-invasive devices that measure SpO2 and pulse rate by applying a sensor to the fingertip. They do not analyze samples taken from the body.

The device description clearly states it's a "portable, non-invasive device intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate". This is a direct measurement of physiological parameters in vivo, not an analysis of a sample in vitro.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

DOA, DQA

Device Description

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 906nm, which is infrared light.

Skin, bone, tissue, and venous vessels normally absorb a constant amount of light overtime. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2.

The power sources of the proposed devices are 2 AAA alkaline batteries. All of the proposed devices have low battery voltage indicator function and all of the proposed devices will automatically power off when there is no signal for longer than 8 seconds.

The proposed devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization. The devices are for prescription. The devices do not contain drug or biological products.

The Pulse Oximeters FS10A,FS20A share the same measurement principle and oximeter sensor and oxygen saturation module and power supply. The indented target population and use environment of the Pulse Oximeters FS10A, FS20A are the same.

The devices are software-driven and the software validation is provided in Section of Software.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

adult patients (weighing ≥ 30 kg)

Intended User / Care Setting

hospitals.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Tests Performed:
The following testing was performed on the Pulse Oximeter FS10A,FS20A in accordance with the requirements of the design control regulations and established quality assurance procedures.
IEC60601-1:2005+CORR.1(2006)+CORR.2(2007),Medical electrical equipment-Part 1:General requirements for basic safety, and essential performance.
IEC60601-1-2:2007, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and tests.
ISO80601-2-61:2011, Medical electrical equipment-Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
ISO10993-1: 2009, Biological evaluation of medical devices -Part 1:Evaluation and testing within a risk management process
ISO10993-5:2009, Biological evaluation of medical devices - PartS5: Tests for In Vitro cytotoxicity.
ISO10993-10:2010, Biological evaluation of medical devices-Part10: Tests for irritation and skin sensitization
In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

Clinical Trial Conclusion:
The Pulse Oximeters FS10A and FS20A share the same pulse oximeter sensor, algorithm and oxygen saturation module. So we considered a clinical test of one of the proposed devices could cover that of other devices. The clinical test of other proposed devices can be exempted. And we conducted clinical test for one of the proposed devices, and the model is FS20A.
The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO80601-2-61:2011, Medical electrical equipment-Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment.
It can be determined from the result of the clinical study that the accuracy Arms of the proposed device is smaller than 2%.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Spo2 Accuracy:
FS10A: 70~~99% is ± 2%, 0~~69% is no definition
FS20A: 70~~100% is ± 2%, 0~~69% is no definition

PR Accuracy: ±3bpm

Predicate Device(s)

K139047

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).

Summary

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the profiles.

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

December 4, 2014

Hunan Accurate Bio-Medical Technology Company Limited Mr. Li Zhang Quality Manager M8-613, No. 8, Lutian Road Changsha National Hi-Tech Industrial Development Zone Changsha, Hunan 410205 CHINA

Re: K141105 Trade/Device Name: Pulse Oximeter, Model FS10A and FS20A Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DOA Dated: November 5, 2014 Received: November 5, 2014

Dear Mr. Zhang:

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.

Page 2 - Mr. Zhang

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 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" (21CFR 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/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Druq Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

510(k) Number (if known)

K141105

Device Name

Pulse Oximeter

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Section 6 - 510(k) Summary

Date of Summary Preparation: 12/04/2014

1. Submitter's Identifications

Submitter's Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Zone, Changsha, Hunan Province, P.R. China Contact Person: Li Zhang Contact Email Address: Email: regulation@accbiomed.com Telephone: +86- 731-89745029 Fax: +86- 731-89745029

2. Correspondent's Identifications

Submitter's Name: Hunan Accurate Bio-Medical Technology Co., Ltd. Address: M8-613, No.8, Lutian Road, Changsha National Hi-Tech Industrial Development Zone, Changsha, Hunan Province, P.R. China Contact Person: Li Zhang Contact Email Address: regulation@accbiomed.com Telephone: +86- 731-89745029 Fax: +86- 731-89745029 3. Name of the Device Device Classification Name: Oximeter

Product Name: Pulse Oximeter Trade Name: Pulse Oximeter Model: FS10A,FS20A Classification Panel: Cardiovascular Product Code: DQA Device Classification: Class II

4. The Predicate Devices

K139047. MD300C1,MD300C2 Fingertip pulse Oximeter 21 CFR 870.2700

5. Device Description

The pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a

dual light source and photo detector. The wavelength of one light source is 660 nm, which is red light; the other is 906nm, which is infrared light.

The devices are software-driven and the software validation is provided in Section of Software.

6. Intended Use of Device

7. Summary of Substantial Equivalence

		FS10A	FS20A
Display Range	Spo2	0~99%	0~100%
	PR	0~250 bpm	0~250 bpm
Measurement
Range	Spo2	70~99%	70~100%
	PR	25~250	25~250
Accuracy	Spo2	70~99%: ±2%
0%~69%: no definition	70~100%: ±2%
0%~69%: no definition
	PR	±3 bpm	±3 bpm
Resolution	Spo2	1%	1%

Table 1: The difference between FS10A and FS20A.

	PR	1 bpm
Display Screen	LED	OLED
Pulse Beep	N	Y
Pulse beat sound	N	Y
Pulse sound On/Off function	N	Y
Pulse waveform display	N	Y
Four direction display	N	Y
The shape and size of shell	The proposed devices have the same appearances and sizes.

Table 2 : The difference between FS10A,FS20A and Predicate

Compariosn Elements	Proposed Device		Predicate Device	Comparison
Device Name	Pulse oximeter		Fingertip pulse Oximeter (K130947)	Similar
Model	FS10A, FS20A		MD300C1,MD300C2	-------
Regulation No.	21 CFR 870.2700		21 CFR 870.2700	Same
Classification	II		II	Same
Classification Name	Oximeter		Oximeter	Same
Product Code	DQA		DQA	Same
Indications for Use	The Pulse Oximeter FS10A and FS20A are portable, non-invasive devices intended for spot check monitoring of arterial hemoglobin oxygen saturation (SpO2) and pulse rate of adult patients (weighing ≥ 30 kg) in hospitals.		The Fingertip Pulse Oximeter MD300C series, are portable, non-invasive devices intended for spot checking of arterial hemoglobin oxygen saturation(SPO2) and pulse rate of adult and pediatric patient at hospital(including clinical use in internist/surgery, Anesthesia, and intensive care units).	Similar
Comparison Statement	The proposed devices have the same indications for use and classification.
Components	The applicant device consists of photo detector and emitter LED, CPU, data display unit and power unit.		detector and emitter LED, signal amplify unit, CPU, data display unit and power unit.	Similar
Design Principle	Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed		Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the	Similar

		normally pulsates and absorbs
variable amount of light during
systole and diastole, as blood
volume increases and decreases.
The ratio of light absorbed at
systole and diastole is translated
into an oxygen saturation
measurement. This measurement
is referred to as SPO2.	light intensity. The arteriolar
bed normally pulsates and
absorbs variable amount of
light during systole and
diastole, as blood volume
increases and decreases. The
ratio of light absorbed at
systole and diastole is
translated into an oxygen
saturation measurement. This
measurement is referred to as
SPO2.
Measurement	Red	660nm	660nm	Same
Wavelength	Infrared	906nm	940nm	The
wavelength of
IR led is
different.
Comparision Statement	The proposed devices have the same design principle and similar components.
Display Type		LED: FS10A
OLED:FS20A	LED:MD300C1
OLED:MD300C2	Same
Working time		Work about 18 hours continuously.	Work for 30 hours continuously	Same
Power Supply		2 * AAA	2 * AAA	Same
Display Data		SPO2, PR	SPO2, PR	Same
Spo2 Display Range		0~99%: FS10A
0~100%: FS20A	0~99%: MD300C1
0~100%: MD300C2	Same
Spo2 Accuracy		FS10A: 70~99% is ± 2%,
0~69% is no definition
FS20A: 70~100% is ± 2%,
0~69% is no definition	MD300C1: 70~~99% is ± 2%, 0~~69% is no definition
MD300C2: 70~~100% is ± 2%, 0~~69% is no definition	Same
Spo2 resolution		1%	1%	Same
PR display range		0~250 bpm	0~254 bpm	The PR range
of the
predicate
device is
bigger.
PR Accuracy		±3bpm	± 2bpm(30~~99bpm) and 2%(100~~235bpm)	The PR
accuracy of
the predicate
device is
higher.
PR resolution		1 bpm	1 bpm	Same
Operating temperature		+5°~+40° C	+5°~+40°C	Same
Relative humidity	10%~95%(Operating and storage)	≤80%(Operating)
≤93%(storage)	Similar
Atmosphere pressure	70~106kPa (Operating)
50~107.4kPa(Storage )	86~106 kPa	Similar
Pulse Beep	Available: FS20A
Not Available: FS10A	Not Available	The predicate
device
doesn't have
the Beep
function.
Comparison Statement	The applicant device has similar device specifications as the predicate device.
Contacting
Material	Battery
cover	ABS + PC	ABS	Similar
	Fingertip
Cushion	Medical Silicon gel	Medical Silicon gel	Same
	Enclosure	ABS + PC /PMMA	ABS	Similar
Comparsion Statement	The contacting materials of applicant device are similar to that of the predicate device.
Performance
Testing	Bench Test	The bench test include SpO2
accuracy test , pulse rate test, FFC
bending test, drop test, function test
and test according to
ISO80601-2-61.All the bench test
results are provide in performance
Testing-Bench	Meet the requirements of
FDA Guidance.	Similar
	Clinical Test	Conformed to ISO80601-2-61
Clinical test for device accuracy is
conducted by the Guangzhou
Huangpu Traditional Chinese
Medicine Hospital. The clinical test
report and protocol are provide in
performance Testing-clinical	Conformed to ISO 9919	Similar
Electromagnetic
Compatibility
Safety	Electrical
Safety	Conformed to IEC60601-1.
The test results are provided in
Electromagnetic Compatibility and
Electrical Safety.	Conformed to IEC60601-1	Same
	Electromagn
etic
Compatibility	Conformed to IEC60601-1-2.
The test results are provided in
Electromagnetic Compatibility and
Electrical Safety.	Conformed to IEC60601-1-2	Same
Software		Moderate level of Concern	Moderate level of
Concern	Same
		Compliance with FDA Guidance for
the content of Premarket Submissions
for Software Contained in Medical
Devices.	Compliance with FDA
Guidance for the content
of
Premarket
Submissions for Software
Contained in Medical
Devices.	Same
Biocompatibility	Medical
Silicone gel	In Vitro No cytotoxic
Cytotoxicity potential

Skin Irritation Test No evidence of
causing
sensitization

Skin Sensitization No evidence of
Test significant
irritation from
the test extract
to rabbits | In Vitro No cytotoxic
Cytotoxici potential
ty
Skin Irritation No evidence
Test of causing
sensitization
Skin No evidence
Sensitizati of
on Test significant
irritation
from the
test extract
to rabbits | Same |
| | ABS + PC
/PMMA
plastic | In Vitro No cytotoxic
Cytotoxicity potential

Skin Irritation Test No evidence of
causing
sensitization

Skin Sensitization No evidence of
Test significant
irritation from
the test extract
to rabbits | In Vitro No cytotoxic
Cytotoxici potential
ty
Skin Irritation No evidence
Test of causing
sensitization
Skin No evidence
Sensitizati of
on Test significant
irritation
from the
test extract
to rabbits | Same |
| | | Label and Labeling | | Compliance with FDA guidance |

8. Substantial Equivalence:

The proposed devices of Pulse Oximeter FS10A, FS20A have the same classification information, same indications and intended use, same design principle, similar product design and specifications, same performance effectiveness, performance safety as the predicate device.

The differences only exist in such contents: Infrared wave length, PR display range and accuracy and Pulse

Beep function. These differences are slight and do not influence the effectiveness and safety of the device.

According to the non-clinical and clinical test results, the proposed devices are as safe, as effective and perform as well as the predicate device. So the proposed devices are Substantially Equivalent(SE) to the predicate device which is US legally market device.

9. Non-Clinical Tests Performed:

The following testing was performed on the Pulse Oximeter FS10A,FS20A in accordance with the requirements of the design control regulations and established quality assurance procedures.

IEC60601-1:2005+CORR.1(2006)+CORR.2(2007),Medical electrical equipment-Part 1:General requirements for basic safety, and essential performance.

IEC60601-1-2:2007, Medical electrical equipment-Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility-Requirements and tests.

ISO80601-2-61:2011, Medical electrical equipment-Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

ISO10993-1: 2009, Biological evaluation of medical devices -Part 1:Evaluation and testing within a risk management process

ISO10993-5:2009, Biological evaluation of medical devices - PartS5: Tests for In Vitro cytotoxicity.

ISO10993-10:2010, Biological evaluation of medical devices-Part10: Tests for irritation and skin sensitization

In addition to the compliance of voluntary standards, the software verification has been carried out according to the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.

10. Clinical Trial Conclusion

The Pulse Oximeters FS10A and FS20A share the same pulse oximeter sensor, algorithm and oxygen saturation module. So we considered a clinical test of one of the proposed devices could cover that of other devices. The clinical test of other proposed devices can be exempted. And we conducted clinical test for one of the proposed devices, and the model is FS20A.

The clinical trial was performed according to Annex EE.2 Procedure for invasive laboratory testing of ISO80601-2-61:2011, Medical electrical equipment-Part 2-6 1: Particular requirements for basic safety and essential performance of pulse oximeter equipment.

It can be determined from the result of the clinical study that the accuracy Arms of the proposed device is smaller than 2%.

11. Substantially Equivalent Conclusion

The proposed device Pulse Oximeter FS10A,FS20A are determined to be Substantially Equivalent (SE) to the predicate device, Fingertip Pulse Oximeter (K130947) MD300C1,MD300C2 in respect of safety and effectiveness.

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