ALPHATEMP CLINICAL THERMOMETER— 510(k) K813333

Substantially Equivalent

Alpha Omega Engineering Corp.

FDA 510(k) clearance K813333 for ALPHATEMP CLINICAL THERMOMETER, Substantially Equivalent on 1981-12-31. Applicant: Alpha Omega Engineering Corp..

Clearance details

Applicant: Alpha Omega Engineering Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1981-11-24
Decision date: 1981-12-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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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.