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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nebulizer (Direct Patient Interface)
510(k) Number K992285
Device Name SALTER AIRE COMPRESSOR
Applicant
Salter Labs
100 W. Sycamore Rd.
Arvin,  CA  93203
Applicant Contact DUANE KAZAL
Correspondent
Salter Labs
100 W. Sycamore Rd.
Arvin,  CA  93203
Correspondent Contact DUANE KAZAL
Regulation Number868.5630
Classification Product Code
CAF  
Date Received07/07/1999
Decision Date 01/07/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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