REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE— 510(k) K050837

Substantially Equivalent

GE Healthcare

FDA 510(k) clearance K050837 for REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE, Substantially Equivalent on 2005-04-27. Applicant: GE Healthcare.

Clearance details

Applicant: GE Healthcare
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2005-04-01
Decision date: 2005-04-27
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.