HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE— 510(k) K874514

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K874514 for HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE, Substantially Equivalent on 1988-01-29. Applicant: Mallinckrodt Critical Care.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1987-11-02
Decision date: 1988-01-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Argyle, NY, 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.