EMOX

K984081 · Emox 911 CC · CAW · Mar 17, 1999 · Anesthesiology

Device Facts

• Record ID: K984081
• Device Name: EMOX
• Applicant: Emox 911 CC
• Product Code: CAW · Anesthesiology
• Decision Date: Mar 17, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5440
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The emOx device is intended to generate oxygen of greater than 99.7% purity for emergency first aid administration.

Device Story

emOx Portable Oxygen Generator; generates oxygen >99.7% purity for emergency first aid. Device provides supplemental oxygen in emergency settings. Operated by first responders or laypersons in emergency situations. Output used for immediate patient respiratory support. Benefits include rapid availability of high-purity oxygen during medical emergencies.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Portable oxygen generator; produces >99.7% purity oxygen. No specific materials, energy sources, or software details provided.

Indications for Use

Indicated for emergency first aid administration of oxygen. No specific patient population, age, or contraindications provided.

Regulatory Classification

Identification

A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 7 1999

Mr. Ivor Duncan EmOx 911 cc P.O. Box 79 Somerset West South Africa 7129

Re: K984081 EmOx Regulatory Class: II (two) Product Code: 73 CAW Dated: January 31, 1999 Received: March 12, 1999

Dear Mr. Duncan:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further announcements regulatory action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Ivor Duncan

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callehan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): 984081

Device Name: emOx Portable Oxygen Generator

Indications for use: The emOx device is intended to generate oxygen of greater than 99.7% purity for emergency first aid administration.

Atl A. Ciall.

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription use_ (Per 21 CFR 801.109

OR

Over the counter Use

AW.