SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE— 510(k) K101244

Substantially Equivalent

Truer Medical, Inc.

FDA 510(k) clearance K101244 for SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE, Substantially Equivalent on 2010-11-18. Applicant: Truer Medical, Inc..

Clearance details

Applicant: Truer Medical, Inc.
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-05-04
Decision date: 2010-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Orange, CA, US

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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.