MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER— 510(k) K861623

Substantially Equivalent

Luxtron

FDA 510(k) clearance K861623 for MODEL 3000 MLULTICHANNEL FLUOROPTIC THERMOMETER, Substantially Equivalent on 1986-08-19. Applicant: Luxtron.

Clearance details

Applicant: Luxtron
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1986-04-29
Decision date: 1986-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, 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.