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FDA 510(k) Application Details - K950018
Device Classification Name
Electrocardiograph
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510(K) Number
K950018
Device Name
Electrocardiograph
Applicant
CAMBRIDGE HEART, INC.
ONE OAK PARK DR.
BEDFORD, MA 01730 US
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M ARIE
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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
01/03/1995
Decision Date
02/29/1996
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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