TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO.— 510(k) K871529

Substantially Equivalent

Western Medical Equipment Corp.

FDA 510(k) clearance K871529 for TMO-1000, TMO-3000, TMO-10,000 NON-INVAS. THERMO., Substantially Equivalent on 1987-10-22. Applicant: Western Medical Equipment Corp..

Clearance details

Applicant: Western Medical Equipment Corp.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1987-04-20
Decision date: 1987-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lafayette, CO, 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.