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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Purifier, Air, Ultraviolet, Medical
510(k) Number K951981
Device Name RXAIR 3000
Applicant
Clean Air Research & Development
13711 Omega Rd.
Dallas,  TX  75244
Applicant Contact CHARLES D HARRIS
Correspondent
Clean Air Research & Development
13711 Omega Rd.
Dallas,  TX  75244
Correspondent Contact CHARLES D HARRIS
Regulation Number880.6500
Classification Product Code
FRA  
Date Received04/27/1995
Decision Date 10/12/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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