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FDA 510(k) Application Details - K001034
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K001034
Device Name
Electrocardiograph
Applicant
CAMBRIDGE HEART, INC.
20310 SW 48TH ST.
FT. LAUDERDALE, FL 33332 US
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Contact
JOHN GREENBAUM
Other 510(k) Applications for this Contact
Regulation Number
870.2340
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Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/31/2000
Decision Date
06/09/2000
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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