JASUN, MODELS DT-01F AND DT-11F

Thermometer, Electronic, Clinical

HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO.,

The following data is part of a premarket notification filed by Hangzhou Hua'an Medical & Health Instruments Co., with the FDA for Jasun, Models Dt-01f And Dt-11f.

Pre-market Notification Details

Device IDK030361
510k NumberK030361
Device Name:JASUN, MODELS DT-01F AND DT-11F
ClassificationThermometer, Electronic, Clinical
Applicant HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., 4960 TAMARACK DR. Barrington,  IL  60010
ContactTing Lu
CorrespondentTing Lu
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., 4960 TAMARACK DR. Barrington,  IL  60010
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-02-03
Decision Date2003-02-21

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