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 |