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FDA 510(k) Application Details - K071130
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K071130
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
UNIVERSAL MEDICAL, INC.
275 PHILLIPS BLVD.
EWING, NJ 08618 US
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Contact
STEVEN ADAMSKY
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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
04/23/2007
Decision Date
05/14/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Abbreviated
Reviewed By Third Party
N
Expedited Review
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