TEMPTREND PEDS AXILLARY TEMP. INDICATOR

Strip, Temperature, Forehead, Liquid Crystal

BIOSYNERGY, INC.

The following data is part of a premarket notification filed by Biosynergy, Inc. with the FDA for Temptrend Peds Axillary Temp. Indicator.

Pre-market Notification Details

Device IDK841913
510k NumberK841913
Device Name:TEMPTREND PEDS AXILLARY TEMP. INDICATOR
ClassificationStrip, Temperature, Forehead, Liquid Crystal
Applicant BIOSYNERGY, INC. 724 WEST ALGONQUIN ROAD Arlington Heights ,  IL  60005 -
ContactSharon B Muir
CorrespondentSharon B Muir
BIOSYNERGY, INC. 724 WEST ALGONQUIN ROAD Arlington Heights ,  IL  60005 -
Product CodeKPD  
CFR Regulation Number880.2200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-05-09
Decision Date1984-11-02

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