BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D— 510(k) K913082

Substantially Equivalent

Respiratory Support Products, Inc.

FDA 510(k) clearance K913082 for BI-TEMP TEMPERATURE MONITOR,MODEL TM-300D, Substantially Equivalent on 1991-12-11. Applicant: Respiratory Support Products, Inc..

Clearance details

Applicant: Respiratory Support Products, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 1991-05-23
Decision date: 1991-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, 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.