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FDA 510(k) Application Details - K130294
Device Classification Name
Electrocardiograph,Ambulatory(Without Analysis)
More FDA Info for this Device
510(K) Number
K130294
Device Name
Electrocardiograph,Ambulatory(Without Analysis)
Applicant
BRAEMAR MANUFACTURING LLC
750 B. STREET, STUITE 1400
SAN DIEGO, CA 92101 US
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Contact
KENT SAYLER
Other 510(k) Applications for this Contact
Regulation Number
870.2800
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Classification Product Code
MWJ
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More FDA Info for this Product Code
Date Received
02/06/2013
Decision Date
10/16/2013
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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