HI-LO TEMP GEN. PURPOSE TEMP. PROBE— 510(k) K801924

Substantially Equivalent

National Catheter Co. Div. Mallinckrodt

FDA 510(k) clearance K801924 for HI-LO TEMP GEN. PURPOSE TEMP. PROBE, Substantially Equivalent on 1980-09-09. Applicant: National Catheter Co. Div. Mallinckrodt.

Clearance details

Applicant: National Catheter Co. Div. Mallinckrodt
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1980-08-12
Decision date: 1980-09-09
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.