C-STAT/1000
Device Facts
| Record ID | K880876 |
|---|---|
| Device Name | C-STAT/1000 |
| Applicant | Sonne Medical, Inc. |
| Product Code | LHC · Physical Medicine |
| Decision Date | May 20, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5950 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature.
