510(k) K831270

DISPOS. MEDICATION NEBULIZER by Hospitak, Inc. — Product Code CAF

K831270 is an FDA 510(k) premarket notification submitted by Hospitak, Inc. for the device "DISPOS. MEDICATION NEBULIZER". The FDA issued a decision of Substantially Equivalent on June 8, 1983. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Hospitak, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
April 19, 1983
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