Cleared Traditional

K821312 - TEMPTREND TEMPERATURE TREND INDICATOR
(FDA 510(k) Clearance)

May 1982
Decision
24d
Days
Class 2
Risk

K821312 is an FDA 510(k) clearance for the TEMPTREND TEMPERATURE TREND INDICATOR. This device is classified as a Strip, Temperature, Forehead, Liquid Crystal (Class II - Special Controls, product code KPD).

Submitted by Liquid Crystal Products, Inc. (Walker, US). The FDA issued a Cleared decision on May 28, 1982, 24 days after receiving the submission on May 4, 1982.

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

Submission Details

510(k) Number K821312 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1982
Decision Date May 28, 1982
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

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