BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520

Thermometer, Electronic, Clinical

BRAUN AG

The following data is part of a premarket notification filed by Braun Ag with the FDA for Braun Thermoscan Irt3020/3500 One Secons Ear Thermometer, Model Irt3020/3520.

Pre-market Notification Details

Device IDK983295
510k NumberK983295
Device Name:BRAUN THERMOSCAN IRT3020/3500 ONE SECONS EAR THERMOMETER, MODEL IRT3020/3520
ClassificationThermometer, Electronic, Clinical
Applicant BRAUN AG 10421 PACIFIC CENTER COURT San Diego,  CA 
ContactFrances E Harrison
CorrespondentFrances E Harrison
BRAUN AG 10421 PACIFIC CENTER COURT San Diego,  CA 
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-09-21
Decision Date1999-03-15
Summary:summary

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