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FDA 510(k) Application Details - K053378
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K053378
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
TMS TELEMEDIZINISCHE SYSTEME GMBH
STADLERSTRASSE 14
CHEMNITZ D-09126 DE
Other 510(k) Applications for this Company
Contact
TILO BORCHARDT
Other 510(k) Applications for this Contact
Regulation Number
870.2920
More FDA Info for this Regulation Number
Classification Product Code
DXH
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/05/2005
Decision Date
02/23/2006
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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