TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237— 510(k) K061942

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K061942 for TYMPANIC TEMPERATURE PROBE WITH FOAM, MODEL M1024233; WITHOUT FOAM MODEL M1024237, Substantially Equivalent on 2006-09-29. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2006-07-10
Decision date: 2006-09-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Needham, MA, 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.