MODEL 63-654 THERMOMETER, ELECTRONICS, CLINICAL— 510(k) K861473

Substantially Equivalent

Radio Shack Div. Tandy Corp.

FDA 510(k) clearance K861473 for MODEL 63-654 THERMOMETER, ELECTRONICS, CLINICAL, Substantially Equivalent on 1986-05-06. Applicant: Radio Shack Div. Tandy Corp..

Clearance details

Applicant: Radio Shack Div. Tandy Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1986-04-22
Decision date: 1986-05-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, 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.