Cleared Traditional

GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA

K100563 · Geon Corporation · General Hospital

Jun 2010

Decision

93d

Days

Class 2

Risk

About This 510(k) Submission

K100563 is an FDA 510(k) clearance for the GEON RAPID DIGITAL THERMOMETER MODEL: MT-B117, MT-B127, MT-B130, MT-B132FA, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Geon Corporation (Flagstaff, US). The FDA issued a Cleared decision on June 2, 2010, 93 days after receiving the submission on March 1, 2010. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K100563 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 2010
Decision Date	June 02, 2010
Days to Decision	93 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement

Device Classification

Product Code	FLL — Continuous Measurement Thermometer
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.2910
Definition	A Continuous Measurement Thermometer Is A Clinical Electronic Thermometer Indicated To Measure The Body Or Skin Temperature Of A Person Continuously Or In Specified Intervals. Under This Regulation, This Product Code Represents Non-exempt Devices. For More Information, See 90 Fr 25889, Available At Https://www.govinfo.gov/content/pkg/fr-2025-06-18/pdf/2025-11207.pdf.