Cleared Traditional

DISPOSABLE TEMPERATURE PROBE

K792426 · Hospitak, Inc. · General Hospital
Jan 1980
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K792426 is an FDA 510(k) clearance for the DISPOSABLE TEMPERATURE PROBE, a Thermometer, Clinical Mercury (Class II — Special Controls, product code FLK), submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 16, 1980, 49 days after receiving the submission on November 28, 1979. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2920.

Submission Details

510(k) Number K792426 FDA.gov
FDA Decision Cleared SESE
Date Received November 28, 1979
Decision Date January 16, 1980
Days to Decision 49 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

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

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