BAIR HUGGER BLOOD/FLUID WARMER— 510(k) K973741

Substantially Equivalent

Augustine Medical, Inc.

FDA 510(k) clearance K973741 for BAIR HUGGER BLOOD/FLUID WARMER, Substantially Equivalent on 1998-04-30. Applicant: Augustine Medical, Inc..

Clearance details

Applicant: Augustine Medical, Inc.
Product code: Code BSB
Advisory panel: Hematology
Date received: 1997-10-01
Decision date: 1998-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code BSB

product code BSB

Death: 5
Malfunction: 1,778
Total: 1,783

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.