BAIR HUGGER MODEL 655 BLANKET— 510(k) K952864
Substantially EquivalentAugustine Medical, Inc.
FDA 510(k) clearance K952864 for BAIR HUGGER MODEL 655 BLANKET, Substantially Equivalent on 1995-09-12. Applicant: Augustine Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Augustine Medical, Inc.
- Product code
- Code DWJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.5900
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code DWJ
view allMore clearances from Augustine Medical, Inc.
view all- K021473 — BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEM
- K020077 — MODIFICATION TO AUGUSTINE MEDICAL WOUND CARE SYSTEM, MODEL 68XXX
- K001149 — AUGUSTINE MEDICAL BAIR HUUGER, MODEL 750 TOTAL TEMPERATURE MANAGEMENT SYSTEM-(MODEL 750 WARMING UNIT, BAIR HUGGER BLANK
- K973741 — BAIR HUGGER BLOOD/FLUID WARMER
- K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET
Adverse events under product code DWJ
product code DWJ- Death
- 7
- Injury
- 679
- Malfunction
- 17,477
- Total
- 18,163
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.