510(k) K913734 ยท DWJ System, Thermal Regulating
BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER
| Applicant | Augustine Medical, Inc., Eden Prairie MN, US |
| Decision | Substantially Equivalent, Oct 23, 1991 |
| Received | Aug 20, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913734
| 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.