ELECTRONIC THERMOMETERS— 510(k) K940686

Substantially Equivalent

American Diagnostic Corp.

FDA 510(k) clearance K940686 for ELECTRONIC THERMOMETERS, Substantially Equivalent on 1994-07-08. Applicant: American Diagnostic Corp..

Clearance details

Applicant: American Diagnostic Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1994-02-16
Decision date: 1994-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Babylon, NY, 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.