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Exhibit 99.11 (DEPARTMENT OF HEALTH & HUMAN SERVICES LOGO) Mr. Kevin McCulloh
 Vice
President of Engineering 
Chad
Therapeutics, Incorporated
21622 Plummer Street 
Chatsworth,
California 91311 Re.
    
    K042142Trade/Device Name: Chad Therapeutics Lotus Models OM-700 and OM-700SRegulation Number: 21 CFR
868.5905

Regulation Name: Noncontinuous Ventilator (IPPB)Regulatory Class: IIProduct Code: NFB

Dated: September 7, 2004Received: September 13, 2004
 Dear Mr. McCulloh: 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. McCulloh 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 (21 CFR 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 yours,-s- Chiu Lin
    
    Chiu Lin, Ph.D.

DirectorDivision of Anesthesiology, General Hospital,Infection Control and Dental DevicesOffice of Device EvaluationCenter for Devices andRadiological Health
 Enclosure