MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2

Nebulizer (direct Patient Interface)

MEDICAL DEPOT, INC.

The following data is part of a premarket notification filed by Medical Depot, Inc. with the FDA for Medical Depot Nebulizer, Model Power Neb 2.

Pre-market Notification Details

Device IDK003344
510k NumberK003344
Device Name:MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2
ClassificationNebulizer (direct Patient Interface)
Applicant MEDICAL DEPOT, INC. 962 ALLEGRO LN. Apollo Beach,  FL  33572
ContactArt Ward
CorrespondentArt Ward
MEDICAL DEPOT, INC. 962 ALLEGRO LN. Apollo Beach,  FL  33572
Product CodeCAF  
CFR Regulation Number868.5630 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-25
Decision Date2001-03-15

NIH GUDID Devices

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