ERGOSELECT/GE

Exerciser, Measuring

ERGOLINE GMBH

The following data is part of a premarket notification filed by Ergoline Gmbh with the FDA for Ergoselect/ge.

Pre-market Notification Details

Device IDK112121
510k NumberK112121
Device Name:ERGOSELECT/GE
ClassificationExerciser, Measuring
Applicant ERGOLINE GMBH SCHWARZWALDSTRASSE 5 Tuttlingen,  DE 78532
ContactAndrea Pecsi
CorrespondentAndrea Pecsi
ERGOLINE GMBH SCHWARZWALDSTRASSE 5 Tuttlingen,  DE 78532
Product CodeISD  
CFR Regulation Number890.5360 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-07-25
Decision Date2012-10-31
Summary:summary

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