The following data is part of a premarket notification filed by Augustine Medical, Inc. with the FDA for Bair Hugger(r) Patient Warm Syst/baby Warm Cover.
| Device ID | K913734 |
| 510k Number | K913734 |
| Device Name: | BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER |
| Classification | System, Thermal Regulating |
| Applicant | AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Contact | Scott D Augustine |
| Correspondent | Scott D Augustine AUGUSTINE MEDICAL, INC. 10393 WEST 70TH ST. Eden Prairie, MN 55344 |
| Product Code | DWJ |
| CFR Regulation Number | 870.5900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-20 |
| Decision Date | 1991-10-23 |