The following data is part of a premarket notification filed by Global Medical Technologies, Inc. with the FDA for Circu-flate 5000 Pressure Relief System.
| Device ID | K943097 |
| 510k Number | K943097 |
| Device Name: | CIRCU-FLATE 5000 PRESSURE RELIEF SYSTEM |
| Classification | Mattress, Air Flotation, Alternating Pressure |
| Applicant | GLOBAL MEDICAL TECHNOLOGIES, INC. 17 HENRY AVE. Park Ridge, NJ 07656 |
| Contact | Arron Mei |
| Correspondent | Arron Mei GLOBAL MEDICAL TECHNOLOGIES, INC. 17 HENRY AVE. Park Ridge, NJ 07656 |
| Product Code | FNM |
| CFR Regulation Number | 880.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-28 |
| Decision Date | 1994-12-23 |