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FDA 510(k) Application Details - K970305
Device Classification Name
Transmitters And Receivers, Electrocardiograph, Telephone
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510(K) Number
K970305
Device Name
Transmitters And Receivers, Electrocardiograph, Telephone
Applicant
MICROMEDICAL, INC.
255 REVERE DR., SUITE 111
NORTHBROOK, IL 60062 US
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Contact
MALCOLM CASTLE
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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
01/27/1997
Decision Date
08/15/1997
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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