The following data is part of a premarket notification filed by Stryker Medical with the FDA for Stryker 5000.
| Device ID | K935949 |
| 510k Number | K935949 |
| Device Name: | STRYKER 5000 |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | STRYKER MEDICAL 6300 S. SPRINKLE RD. Kalamazoo, MI 49001 -9799 |
| Contact | Chad Coberly |
| Correspondent | Chad Coberly STRYKER MEDICAL 6300 S. SPRINKLE RD. Kalamazoo, MI 49001 -9799 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-06-17 |