SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II)— 510(k) K883603

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K883603 for SARNS TEMP. CONTROL AND MONITOR SYSTEM (TCM II), Substantially Equivalent on 1988-11-03. Applicant: 3M Health Care, Sarns.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DWC
Advisory panel: Cardiovascular
Date received: 1988-08-23
Decision date: 1988-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

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Adverse events under product code DWC

product code DWC

Death: 124
Injury: 233
Malfunction: 3,727
Total: 4,084

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.