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FDA 510(k) Application Details - K982090
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K982090
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
PACEART, INC.
377 ROUTE 17 SOUTH
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
06/15/1998
Decision Date
01/26/1999
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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