HOT DOG PATIENT WARMING SYSTEM— 510(k) K052392

Substantially Equivalent

Augustine Biomedical & Design, LLC

FDA 510(k) clearance K052392 for HOT DOG PATIENT WARMING SYSTEM, Substantially Equivalent on 2006-05-04. Applicant: Augustine Biomedical & Design, LLC.

Clearance details

Applicant: Augustine Biomedical & Design, LLC
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2005-08-31
Decision date: 2006-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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.