THERMAL REGULATION SYSTEM BLANKET— 510(k) K964377

Substantially Equivalent

Gibeck, Inc.

FDA 510(k) clearance K964377 for THERMAL REGULATION SYSTEM BLANKET, Substantially Equivalent on 1997-04-23. Applicant: Gibeck, Inc..

Clearance details

Applicant: Gibeck, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 1996-11-01
Decision date: 1997-04-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, 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.