K874523

Substantially Equivalent

MODIFIED TYMPANIC & ESOPHAGEAL/RECTAL TEMP. SENSOR

Applicant: Mon-A-Therm, Inc.
Product code: FLL
Advisory panel: General Hospital
Date received: 1987-11-02
Decision date: 1988-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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.