510(k) K001149 ยท DWJ System, Thermal Regulating
AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
| Applicant | Augustine Medical, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Sep 6, 2000 |
| Received | Apr 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001149
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2005 | Arizant Inc Bair Hugger Temperature Management Blanket, Model 555 Pediatric Full Access Blanket. Use only with a Bair Hugger temperature managemen unit. Not Sterile. Do not use if primary packaging has been pr Terminated |
DWJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.