Cleared Traditional

K110956 - MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
(FDA 510(k) Clearance)

K110956 · Medivance, Inc. · General Hospital

Jul 2011

Decision

104d

Days

Class 2

Risk

K110956 is an FDA 510(k) clearance for the MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR, a Continuous Measurement Thermometer (Class II — Special Controls, product code FLL), submitted by Medivance, Inc. (Louisville, US). The FDA issued a Cleared decision on July 18, 2011, 104 days after receiving the submission on April 5, 2011. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2910.

Submission Details

510(k) Number	K110956 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 05, 2011
Decision Date	July 18, 2011
Days to Decision	104 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

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.