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.
Device ID | K003344 |
510k Number | K003344 |
Device Name: | MEDICAL DEPOT NEBULIZER, MODEL POWER NEB 2 |
Classification | Nebulizer (direct Patient Interface) |
Applicant | MEDICAL DEPOT, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
Contact | Art Ward |
Correspondent | Art Ward MEDICAL DEPOT, INC. 962 ALLEGRO LN. Apollo Beach, FL 33572 |
Product Code | CAF |
CFR Regulation Number | 868.5630 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-10-25 |
Decision Date | 2001-03-15 |