The following data is part of a premarket notification filed by Superior Healthcare Group, Inc. with the FDA for Instrument Warmer.
| Device ID | K925530 |
| 510k Number | K925530 |
| Device Name: | INSTRUMENT WARMER |
| Classification | Bed, Pediatric Open Hospital |
| Applicant | SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Contact | Maureen G Mccabe |
| Correspondent | Maureen G Mccabe SUPERIOR HEALTHCARE GROUP, INC. CUMBERLAND INDUSTRIAL PARK Cumberland, RI 02864 |
| Product Code | FMS |
| CFR Regulation Number | 880.5140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-11-02 |
| Decision Date | 1993-06-18 |