Cleared Traditional

KENTEMP

K953465 · Kentron Health Care, Inc. · General Hospital
Dec 1995
Decision
144d
Days
Class 2
Risk

About This 510(k) Submission

K953465 is an FDA 510(k) clearance for the KENTEMP, a Thermometer, Clinical Mercury (Class II — Special Controls, product code FLK), submitted by Kentron Health Care, Inc. (Hollywood, US). The FDA issued a Cleared decision on December 15, 1995, 144 days after receiving the submission on July 24, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2920.

Submission Details

510(k) Number K953465 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1995
Decision Date December 15, 1995
Days to Decision 144 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code FLK — Thermometer, Clinical Mercury
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2920

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