The following data is part of a premarket notification filed by Apex Medical, Inc. with the FDA for Apex Medical Air Pumps.
| Device ID | K933965 |
| 510k Number | K933965 |
| Device Name: | APEX MEDICAL AIR PUMPS |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | APEX MEDICAL, INC. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller APEX MEDICAL, INC. EAST TOWER, SUITE 600 2425 WEST OLYMPIC BOULEVARD Santa Monica, CA 90404 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-16 |
| Decision Date | 1994-03-17 |