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FDA 510(k) Application Details - K122095
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K122095
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
Emergo Europe Consulting BV
PRINSESSEGRACHT 20
DEN HAAG 2514 NL
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Contact
RACHIDA ZIANI
Other 510(k) Applications for this Contact
Regulation Number
870.2910
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Classification Product Code
DRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/12/2012
Decision Date
07/26/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
Y
Expedited Review
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