SK MED M201 PLUS MIXER by SK MED

The M201Plus Mixer is used to deliver a mixture of air and oxygen in conjunction with oxygen hoods, resuscitation bags, masks, and nasal cannulas. The user can adjust the oxygen percentage within a range of 21-100% and the flow rate within a range of 0-30 liters per minute. Additionally, the device monitors the air supply pressure, oxygen supply pressure, battery voltage, and output oxygen percentage.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves a device meets acceptance criteria, sample sizes, data provenance, ground truth establishment, or any information related to AI or multi-reader multi-case studies.

The document is a 510(k) premarket notification letter from the FDA to SK Med, Incorporated, concerning their SK Med M201 Plus Mixer, classified as a Breathing Gas Mixer. It primarily discusses the substantial equivalence determination of the device and regulatory compliance requirements.

Therefore, I cannot provide the requested table and information.

Summary

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 1 2003

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

Re: K031707

Trade/Device Name: SK Med M201 Plus Mixer Regulation Number: 21 CFR 868.5330 Regulation Name: Breathing Gas Mixer Regulatory Class: II Product Code: BZR, CCL Dated: July 23, 2003 Received: July 24, 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 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. Ghosh

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results 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), please contact the Office of Compliance at (301) 594-4646. 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 Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Patricio Cucurella

Susan Runner, DDS, MA Interim 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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Attachment 1 Indications for Use Statement

510(k) Number: K ○ 3 | 707

Device Name: SK Med M201Plus Mixer

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

P. Cussenat for Vente.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number KU3707

Regulation Number and Section

§ 868.5330 Breathing gas mixer.

(a)
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.(b)
Classification. Class II (performance standards).