THERMO BUDDY, MODELS TB-100, TB-110, TB-120

Thermometer, Electronic, Clinical

HUBDIC CO., LTD

The following data is part of a premarket notification filed by Hubdic Co., Ltd with the FDA for Thermo Buddy, Models Tb-100, Tb-110, Tb-120.

Pre-market Notification Details

Device IDK023412
510k NumberK023412
Device Name:THERMO BUDDY, MODELS TB-100, TB-110, TB-120
ClassificationThermometer, Electronic, Clinical
Applicant HUBDIC CO., LTD 11820 RED HIBISCUS DR. Bonita Springs,  FL  34135
ContactGuenter Ginsberg
CorrespondentGuenter Ginsberg
HUBDIC CO., LTD 11820 RED HIBISCUS DR. Bonita Springs,  FL  34135
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-11
Decision Date2003-04-09
Summary:summary

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