GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA— 510(k) K100563

Substantially Equivalent

Geon Corporation

FDA 510(k) clearance K100563 for GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA, Substantially Equivalent on 2010-06-02. Applicant: Geon Corporation.

Clearance details

Applicant: Geon Corporation
Product code: Code FLL
Advisory panel: General Hospital
Date received: 2010-03-01
Decision date: 2010-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Flagstaff, AZ, 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.