FUNET AMY MAMA BODY THERMOMETER

Thermometer, Electronic, Clinical

FUNAI RADIO & COMMUNICATIONS CORP.

The following data is part of a premarket notification filed by Funai Radio & Communications Corp. with the FDA for Funet Amy Mama Body Thermometer.

Pre-market Notification Details

Device IDK003326
510k NumberK003326
Device Name:FUNET AMY MAMA BODY THERMOMETER
ClassificationThermometer, Electronic, Clinical
Applicant FUNAI RADIO & COMMUNICATIONS CORP. 3F, NO. 24 CHIEN KUO RD. T.E.P.Z. TANTZU Taichung,  TW 427
ContactJohn Lin
CorrespondentJohn Lin
FUNAI RADIO & COMMUNICATIONS CORP. 3F, NO. 24 CHIEN KUO RD. T.E.P.Z. TANTZU Taichung,  TW 427
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-10-24
Decision Date2001-04-11

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