FIRST TEMP— 510(k) K853713

Substantially Equivalent

Intelligent Medical Systems

FDA 510(k) clearance K853713 for FIRST TEMP, Substantially Equivalent on 1985-11-01. Applicant: Intelligent Medical Systems.

Clearance details

Applicant: Intelligent Medical Systems
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1985-09-05
Decision date: 1985-11-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, 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.