510(k) K883964

AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER by Baxter Healthcare Corp — Product Code CAF

K883964 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "AIRLIFE MISTY NEB MEDICATION SYSTEM W/FILTER". The FDA issued a decision of Substantially Equivalent on Nov 30, 1988. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Baxter Healthcare Corp has 507 other 510(k) clearances on record.

Clearance details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 30, 1988
Date Received
Sep 20, 1988
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
510(k)

Source: FDA 510(k) database entry for K883964. Report a data issue: hello@regdatalab.com.