SHILEY TEMPERATURE MONITOR— 510(k) K802147

Substantially Equivalent

Shiley, Inc.

FDA 510(k) clearance K802147 for SHILEY TEMPERATURE MONITOR, Substantially Equivalent on 1980-09-16. Applicant: Shiley, Inc..

Clearance details

Applicant: Shiley, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1980-09-05
Decision date: 1980-09-16
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.