RESPIFIT S, MODEL RS-LR1001004

Spirometer, Therapeutic (incentive)

EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH

The following data is part of a premarket notification filed by Eumedics Medizintechnik Und Marketing Gmbh with the FDA for Respifit S, Model Rs-lr1001004.

Pre-market Notification Details

Device IDK080299
510k NumberK080299
Device Name:RESPIFIT S, MODEL RS-LR1001004
ClassificationSpirometer, Therapeutic (incentive)
Applicant EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH 1341 W FULLERTON SUITE 103 Chicago,  IL  60014
ContactDavid Levine
CorrespondentDavid Levine
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH 1341 W FULLERTON SUITE 103 Chicago,  IL  60014
Product CodeBWF  
CFR Regulation Number868.5690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-02-05
Decision Date2009-01-13
Summary:summary

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