INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1— 510(k) K051419

Name: FDA 510(k) clearance K051419
Creator: U.S. Food and Drug Administration
Published: 2006-04-27

Substantially Equivalent

Inditherm Medical

FDA 510(k) clearance K051419 for INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1, Substantially Equivalent on 2006-04-27. Applicant: Inditherm Medical. Device class: 2.

Clearance details

Applicant: Inditherm Medical
Product code: Code DWJ
Device class: Class 2
Regulation: 21 CFR 870.5900
Advisory panel: Cardiovascular
Date received: 2005-06-01
Decision date: 2006-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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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.