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FDA 510(k) Application Details - K011345
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K011345
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
REYNOLDS MEDICAL LTD.
377 RT. 17 S.
HASBROUCK HEIGHTS, NJ 07604 US
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GEORGE MYERS
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Regulation Number
870.2920
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Classification Product Code
DXH
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More FDA Info for this Product Code
Date Received
05/02/2001
Decision Date
07/20/2001
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
N
Expedited Review
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