510(k) K790925

NEBULIZER WITH 4-WAY T NO M-174 by Mem Medical, Inc. — Product Code CAF

K790925 is an FDA 510(k) premarket notification submitted by Mem Medical, Inc. for the device "NEBULIZER WITH 4-WAY T NO M-174". The FDA issued a decision of Substantially Equivalent on May 21, 1979. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Mem Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 21, 1979
Date Received
May 15, 1979
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