PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007— 510(k) K012974

Substantially Equivalent

Prizm Medical, Inc.

FDA 510(k) clearance K012974 for PRIZM MEDICAL INC. THERMOTRACE INFRARED THERMOMETER MODELS 15004 AND 15007, Substantially Equivalent on 2002-07-23. Applicant: Prizm Medical, Inc..

Clearance details

Applicant: Prizm Medical, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2001-09-05
Decision date: 2002-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dunwoody, GA, 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.