510(k) K003344

MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 by Medical Depot, Inc. — Product Code CAF

K003344 is an FDA 510(k) premarket notification submitted by Medical Depot, Inc. for the device "MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2". The FDA issued a decision of Substantially Equivalent on March 15, 2001. The device falls under product code CAF (Nebulizer (Direct Patient Interface)), a Class II device regulated under 21 CFR 868.5630. Medical Depot, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 15, 2001
Date Received
October 25, 2000
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