CHECK MATE #1850 ELEC. DIGITAL THERMO— 510(k) K823493

Substantially Equivalent

Bristoline, Inc.

FDA 510(k) clearance K823493 for CHECK MATE #1850 ELEC. DIGITAL THERMO, Substantially Equivalent on 1983-02-28. Applicant: Bristoline, Inc..

Clearance details

Applicant: Bristoline, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1982-11-23
Decision date: 1983-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.