LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL— 510(k) K083336

Substantially Equivalent

Smiths Medical Asd, Inc.

FDA 510(k) clearance K083336 for LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL, Substantially Equivalent on 2009-06-03. Applicant: Smiths Medical Asd, Inc..

Clearance details

Applicant: Smiths Medical Asd, Inc.
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2008-11-12
Decision date: 2009-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rockland, MA, 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.