DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A— 510(k) K955142

Substantially Equivalent

Salutron, Inc.

FDA 510(k) clearance K955142 for DIGITAL CLINICAL THERMOMETER, MODELS ST-823, ST-823A, ST-813A & ST-814A, Substantially Equivalent on 1995-12-29. Applicant: Salutron, Inc..

Clearance details

Applicant: Salutron, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1995-11-13
Decision date: 1995-12-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danville, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code FLL

product code FLL

Death: 3
Malfunction: 557
Total: 560

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.