CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM

Thermometer, Electronic, Clinical

GAMBRO, INC.

The following data is part of a premarket notification filed by Gambro, Inc. with the FDA for Craftemp Et 3045 Electronic Thermometry System.

Pre-market Notification Details

Device IDK852454
510k NumberK852454
Device Name:CRAFTEMP ET 3045 ELECTRONIC THERMOMETRY SYSTEM
ClassificationThermometer, Electronic, Clinical
Applicant GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
ContactJeffrey R Shideman
CorrespondentJeffrey R Shideman
GAMBRO, INC. 600 KNIGHTSBRIDGE PKWY. Lincolnshire,  IL  60069
Product CodeFLL  
CFR Regulation Number880.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-10
Decision Date1985-08-16

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