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FDA 510(k) Application Details - K062397
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
More FDA Info for this Device
510(K) Number
K062397
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
DEL MAR REYNOLDS MEDICAL, LTD.
377 ROUTE 17 S
HASBROUCK HEIGHTS, NJ 07604 US
Other 510(k) Applications for this Company
Contact
GEORGE MYERS
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
08/16/2006
Decision Date
01/25/2007
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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