BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER— 510(k) K913734

Substantially Equivalent

Augustine Medical, Inc.

FDA 510(k) clearance K913734 for BAIR HUGGER(R) PATIENT WARM SYST/BABY WARM COVER, Substantially Equivalent on 1991-10-23. Applicant: Augustine Medical, Inc..

Clearance details

Applicant: Augustine Medical, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1991-08-20
Decision date: 1991-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

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Adverse events under product code DWJ

product code DWJ

Death: 7
Injury: 679
Malfunction: 17,477
Total: 18,163

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.