510(k) K992285

SALTER AIRE COMPRESSOR by Salter Labs — Product Code CAF

K992285 is an FDA 510(k) premarket notification submitted by Salter Labs for the device "SALTER AIRE COMPRESSOR". The FDA issued a decision of Substantially Equivalent on January 7, 2000. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Salter Labs has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2000
Date Received
July 7, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nebulizer (Direct Patient Interface)
Device Class
Class II
Regulation Number
868.5630
Review Panel
AN
Submission Type