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FDA 510(k) Application Details - K072008
Device Classification Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
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510(K) Number
K072008
Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Applicant
BRAEMAR, INC.
1285 CORPORATE CENTER DR.
SUITE 150
EAGAN, MN 55121 US
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Contact
DARREN DERSHEM
Other 510(k) Applications for this Contact
Regulation Number
870.2910
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Classification Product Code
DRG
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More FDA Info for this Product Code
Date Received
07/23/2007
Decision Date
10/03/2007
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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