MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM
Device Facts
| Record ID | K933726 |
|---|---|
| Device Name | MODIFICATION OF BAIR HUGGER PATIENT WARMING SYSTEM |
| Applicant | Augustine Medical, Inc. |
| Product Code | LHC · Physical Medicine |
| Decision Date | Jan 28, 1994 |
| 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.
