COR12+

Recorder, Magnetic Tape, Medical

VIASYS HEALTHCARE GMBH

The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Cor12+.

Pre-market Notification Details

Device IDK091505
510k NumberK091505
Device Name:COR12+
ClassificationRecorder, Magnetic Tape, Medical
Applicant VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg,  DE 97204
ContactThomas Rust
CorrespondentStefan Preiss
TUV SUD AMERICA INC. 1775 OLD HIGHWAY 8 NW New Brighton,  MN  55112 -1891
Product CodeDSH  
CFR Regulation Number870.2800 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedYes
Combination ProductNo
Date Received2009-05-21
Decision Date2009-06-10
Summary:summary

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