BAIR HUGGER BLOOD/FLUID WARMER— 510(k) K973741
Substantially EquivalentAugustine Medical, Inc.
FDA 510(k) clearance K973741 for BAIR HUGGER BLOOD/FLUID WARMER, Substantially Equivalent on 1998-04-30. Applicant: Augustine Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Augustine Medical, Inc.
- Product code
- Code BSB
- Device class
- Class 2
- Regulation
- 21 CFR 864.9205
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Eden Prairie, MN, US
Recent devices under product code BSB
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
- K964673 — BAIR HUGGER MODEL 630 CARDIAC BLANKET
- K963293 — AUGUSTINE MEDICAL WOUND CARE SYSTEM MODEL 68XXX
Adverse events under product code BSB
product code BSB- Death
- 5
- Malfunction
- 1,778
- Total
- 1,783
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 →
Recalls naming K973741
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K973741.
Data sourced from openFDA. This site is unofficial and independent of the FDA.