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FDA 510(k) Application Details - K963198
Device Classification Name
Electrocardiograph
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510(K) Number
K963198
Device Name
Electrocardiograph
Applicant
METRON U.S., INC.
1345 MONROE, N.W., #255A
GRAND RAPIDS, MI 49505 US
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Contact
JIM QUINN
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Regulation Number
870.2340
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Classification Product Code
DPS
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More FDA Info for this Product Code
Date Received
08/15/1996
Decision Date
03/05/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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