SARNS WARMER, PART #164975 AND #164980— 510(k) K873813

Name: FDA 510(k) clearance K873813
Creator: U.S. Food and Drug Administration
Published: 1987-11-06

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K873813 for SARNS WARMER, PART #164975 AND #164980, Substantially Equivalent on 1987-11-06. Applicant: 3M Health Care, Sarns. Device class: 2.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DWC
Device class: Class 2
Regulation: 21 CFR 870.4250
Advisory panel: Cardiovascular
Date received: 1987-09-18
Decision date: 1987-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ann Arbor, MI, US

Download summary PDF View on FDA.gov ↗

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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.