The following data is part of a premarket notification filed by Augustine Medical, Inc. with the FDA for Bair Hugger Blood/fluid Warmer.
| Device ID | K973741 |
| 510k Number | K973741 |
| Device Name: | BAIR HUGGER BLOOD/FLUID WARMER |
| Classification | Warmer, Blood, Non-electromagnetic Radiation |
| 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 | BSB |
| CFR Regulation Number | 864.9205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-01 |
| Decision Date | 1998-04-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00608223295007 | K973741 | 000 |
| 30608223242408 | K973741 | 000 |
| 30608223242507 | K973741 | 000 |
| 30608223243658 | K973741 | 000 |
| 30608223243702 | K973741 | 000 |
| 30608223244501 | K973741 | 000 |
| 50608223242006 | K973741 | 000 |
| 50608223242341 | K973741 | 000 |
| 50608223242402 | K973741 | 000 |
| 30608223242347 | K973741 | 000 |
| 30608223242002 | K973741 | 000 |
| 50707387792645 | K973741 | 000 |
| 50707387792676 | K973741 | 000 |
| 50707387792683 | K973741 | 000 |
| 50707387792706 | K973741 | 000 |
| 50707387792713 | K973741 | 000 |
| 50707387805000 | K973741 | 000 |
| 50707387803297 | K973741 | 000 |
| 50707387803419 | K973741 | 000 |
| 50608223242501 | K973741 | 000 |
| 50608223243553 | K973741 | 000 |
| 50707387781472 | K973741 | 000 |
| 50707387781489 | K973741 | 000 |
| 50707387781946 | K973741 | 000 |
| 00707387781491 | K973741 | 000 |
| 00707387781590 | K973741 | 000 |
| 00707387781859 | K973741 | 000 |
| 00608223245002 | K973741 | 000 |
| 00608223245330 | K973741 | 000 |
| 50707387781465 | K973741 | 000 |
| 50707387781441 | K973741 | 000 |
| 50608223243652 | K973741 | 000 |
| 50608223243706 | K973741 | 000 |
| 50608223244505 | K973741 | 000 |
| 50608223900302 | K973741 | 000 |
| 50707387781397 | K973741 | 000 |
| 50707387781410 | K973741 | 000 |
| 50707387781427 | K973741 | 000 |
| 50707387781434 | K973741 | 000 |
| 50707387808995 | K973741 | 000 |