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FDA 510(k) Application Details - K071953
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
More FDA Info for this Device
510(K) Number
K071953
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
RTX HEALTHCARE A/S
STROEMMEN 6
NOERRESUNDBY DK-9400 DK
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Contact
NIELS O ANDERSON
Other 510(k) Applications for this Contact
Regulation Number
870.2910
More FDA Info for this Regulation Number
Classification Product Code
DRG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/16/2007
Decision Date
08/08/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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