DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020

Thermometer, Electronic, Clinical

ACTHERM, INC.

The following data is part of a premarket notification filed by Actherm, Inc. with the FDA for Digital Clinical Thermometer, Model Act 3020.

Pre-market Notification Details

Device IDK021614
510k NumberK021614
Device Name:DIGITAL CLINICAL THERMOMETER, MODEL ACT 3020
ClassificationThermometer, Electronic, Clinical
Applicant ACTHERM, INC. 6TH F, NO 85 KUAN-MIN 6 ROAD JUBEI 302 Hsinchu,  TW 302
ContactRichard Hsieh
CorrespondentRichard Hsieh
ACTHERM, INC. 6TH F, NO 85 KUAN-MIN 6 ROAD JUBEI 302 Hsinchu,  TW 302
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-05-16
Decision Date2002-05-30

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