THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM— 510(k) K844056

Substantially Equivalent

Sensortek, Inc.

FDA 510(k) clearance K844056 for THERMOCOUPLE SENSORS, ACCESS. FOR ELECTRONIC THERM, Substantially Equivalent on 1985-01-09. Applicant: Sensortek, Inc..

Clearance details

Applicant: Sensortek, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1984-10-18
Decision date: 1985-01-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clifton, NJ, 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.