ARIA LX CPAP SYSTEM
Device Facts
| Record ID | K993307 |
|---|---|
| Device Name | ARIA LX CPAP SYSTEM |
| Applicant | Respironics, Inc. |
| Product Code | BZD · Anesthesiology |
| Decision Date | Oct 27, 1999 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 868.5905 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.
Submission Summary (Full Text)
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Page 2 - Mr. David J. Vanella
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 (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
formuta A Waterhausen for,
Wolf Sapirstein, M.D. Acting Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
