SK MED ME202 MONITORING MIXER

K031860 · Sk Med · BZR · Jan 21, 2004 · Anesthesiology

Device Facts

• Record ID: K031860
• Device Name: SK MED ME202 MONITORING MIXER
• Applicant: Sk Med
• Product Code: BZR · Anesthesiology
• Decision Date: Jan 21, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5330
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The M202 Monitoring Mixer is intended to mix air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmcter (1 to 12 I.PM). The device is a prescription device and is intended for use within the hospital or institutional environment.

Device Story

The SK Med M202 Monitoring Mixer is a gas mixing device designed for hospital or institutional use. It accepts air and oxygen as inputs and mixes them to achieve a clinician-prescribed oxygen concentration. The mixed gas is delivered to the patient via a flowmeter at rates ranging from 1 to 12 LPM. The device is operated by healthcare professionals to provide controlled oxygen therapy. It functions as a mechanical gas mixer to ensure accurate gas concentration delivery, aiding in respiratory support and clinical decision-making regarding patient oxygenation levels.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

The device is a mechanical breathing gas mixer (21 CFR 868.5330). It utilizes a pneumatic mixing system to combine air and oxygen. It features a flowmeter output range of 1-12 LPM. The device is designed for institutional use and does not incorporate electronic software or digital algorithms.

Indications for Use

Indicated for patients requiring supplemental oxygen at prescribed concentrations delivered via flowmeter (1-12 LPM) in hospital or institutional settings. Prescription use only.

Regulatory Classification

Identification

A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 2 1 2004

Mr. Dipak Ghosh President SK Med, Incorporated 16000 Sherman Way # 224 Van Nuys, California 91406-4057

Re: K031860

Trade/Devicc Name: SK Med M202 Mixer Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR, CCL Dated: October 31, 2003 Received: November 4, 2003

Dear Mr. Ghosh:

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 received above and hat he enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to ae rood Cosmetic Act (Act) that do not require approval of a premarket the rederal + 600; Drag, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your devilos to such additional controls. Existing major regulations affecting (I NFA), it may to subject to Saccode of Federal Regulations, Title 21, Parts 800 to 898. In your device ear of 10 lower announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Ghosh

Please be advised that FDA's issuance of a substantial equivalence determination does not mcan that FDA has made a determination that your device complies with other requirements moun that + Dr mas may Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration r od linest compry with a 807); labeling (21 CFR Part 801); good manufacturing practice and ilouing (2) = 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms reter notification. The FDA finding of substantial equivalence of your device to a premits in the first and in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), n you deems the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Into overn of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Clubs
Chin Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number: K031860

Device Name: SK Med M202 Monitoring Mixer

## Indications For Use:

The M202 Monitoring Mixer is intended to mix air and oxygen gases and provide the mixed gas at the prescribed oxygen concentration level via flowmcter (1 to 12 I.PM). The device is a prescription device and is intended for use within the hospital or institutional environment.

Prescription Use yes

AND/OR

Over-The-Counter Use _

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

A. Wutrich
Division Sign-On

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ign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices

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