DIGITAL THERMOMETER

Thermometer, Electronic, Clinical

MICRO IDEA INSTRUMENT CO., LTD.

The following data is part of a premarket notification filed by Micro Idea Instrument Co., Ltd. with the FDA for Digital Thermometer.

Pre-market Notification Details

Device IDK851146
510k NumberK851146
Device Name:DIGITAL THERMOMETER
ClassificationThermometer, Electronic, Clinical
Applicant MICRO IDEA INSTRUMENT CO., LTD. R. 501, NO 147, SEC. 2 CHIEN KUO North Road Taipei, Taiwan,  TW
ContactLin
CorrespondentLin
MICRO IDEA INSTRUMENT CO., LTD. R. 501, NO 147, SEC. 2 CHIEN KUO North Road Taipei, Taiwan,  TW
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-21
Decision Date1985-05-23

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10328785000457 K851146 000
00328785000443 K851146 000
00328785000269 K851146 000
B268Y7078A71 K851146 000

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