PROBE, TEMPERATURE, SYSTEM, SARNS— 510(k) K770709

Substantially Equivalent

3M Health Care, Sarns

FDA 510(k) clearance K770709 for PROBE, TEMPERATURE, SYSTEM, SARNS, Substantially Equivalent on 1977-04-27. Applicant: 3M Health Care, Sarns.

Clearance details

Applicant: 3M Health Care, Sarns
Product code: Code DRF
Advisory panel: Cardiovascular
Date received: 1977-04-18
Decision date: 1977-04-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DRF

product code DRF

Death: 127
Injury: 1,676
Malfunction: 2,003
Other: 1
Total: 3,807

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.