Cleared Traditional

K903307 - TEMP MARQ TEMPERATURE TREND INDICATOR
(FDA 510(k) Clearance)

Aug 1990
Decision
24d
Days
Class 2
Risk

K903307 is an FDA 510(k) clearance for the TEMP MARQ TEMPERATURE TREND INDICATOR. This device is classified as a Strip, Temperature, Forehead, Liquid Crystal (Class II - Special Controls, product code KPD).

Submitted by Marquest Medical Products, Inc. (Englewood, US). The FDA issued a Cleared decision on August 17, 1990, 24 days after receiving the submission on July 24, 1990.

This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.2200.

Submission Details

510(k) Number K903307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date August 17, 1990
Days to Decision 24 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary

Device Classification

Product Code KPD — Strip, Temperature, Forehead, Liquid Crystal
Device Class Class II - Special Controls
CFR Regulation 21 CFR 880.2200