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DEPARTMENT OF IIBALTH & HUMAN SERVICES Publlc Htelth Service 

JAN - 3 !108 

Food and Drug Adminiatratlon 

9200 CorpOf'ete Boulevard 

Rockville MO 2:0850 

Delphi Medical Systems 

C/0 Mr. Jeff D. Rongero 

Senior Project Engineer 

Underwriters Laboratories, Incorporated 

12 Laboratory Drive 

Research Triangle, North Carolina 27709 

Re: K073242 

TradeJDevice Name: Portable Oxygen Concentrator 

Regulation Number: 868.5440 

Regulation Name: Portable Oxygen Generator 

Regulatory Class: II 

Product Code:· CAW 

Dated: December 17,2007 

Received: December 19, 2007 

Dear Mr. Rongero: 

We have reviewed your Section S l O(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 preJTUll'ket 

approval application (PMA). You may, therefore, market the device, subject to the general 

controls provisions of the Act. The general controls provisions of the Acl 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 ill 

(PMA), it may be subject to such additional controls. Existing major regulations affecting 

your device can be found in the Code of Federal Reguletions, Title 21, Parts 800 to 898. In 

~tuu on, FDA may publish further announcements concerning ynur device in the ~eral 

~· 

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. Page 2 - Mr. Rongero 

Please be advised that FDA ':s is:suuuce of a ~ubstantial 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 mdiation 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 51 O(k) 

premarl<:et 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 d.evice to proceed to the market. 

If you desire specific advice fot your device on our labeling regulation (21 CFR Part 80 I), 

please contact the Office of Compliance at (240) 276-0120. 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, Intematio1!3.l and Consumer Assistance at its toll-fTee 

number (800) 638-2041 or (301) 443-6597 or at its Internet address 

tt!?://www.fda gov/cdrh/industry supoortlindex htrnl . 

Enclosure 

g,

ce I yours, 

fl· ..12a.t~ -u ~Q C . in, Ph.D. . . 

Director 

Division of Anesthesiology, General Hospital, 

Infection CQntrol and Dental Devices 

Office of Device Evaluation 

Center for Devices and 

Radiological Health 

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DE:LPHI 

Medical Systems 

5725 Delphi Drive Troy, Ml 48098·2815 USA 

·section IV: Indications for Use Statement 

Applicant: Delphi Medical Systems 

510(k) Number: 

Device Name: Portable Oxygen Concentrator 

Indications for Use: 

The Portable Oxygen Concentrator is Intended to provide supplemental oxygen 

in a home, Institutional, or travel environment . 

Pr scrlption Use Only: _X_ Over-the-Counter Use: 

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

PAGE IF NEEDED) . 

Portable Oxygen Concentrator· 

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