Astopad Patient Warming System— 510(k) K202197

Substantially Equivalent

Stihler Electronic GmbH

FDA 510(k) clearance K202197 for Astopad Patient Warming System, Substantially Equivalent on 2020-09-04. Applicant: Stihler Electronic GmbH.

Clearance details

Applicant: Stihler Electronic GmbH
Product code: Code DWJ
Advisory panel: Cardiovascular
Date received: 2020-08-05
Decision date: 2020-09-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Stuttgart, DE

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.