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FDA 510(k) Application Details - K013717
Device Classification Name
Electrocardiograph
More FDA Info for this Device
510(K) Number
K013717
Device Name
Electrocardiograph
Applicant
BRENTWOOD MEDICAL TECHNOLOGY CORP.
3300 FUJITA ST.
TORRANCE, CA 90505 US
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Contact
RUOMEI ZHANG
Other 510(k) Applications for this Contact
Regulation Number
870.2340
More FDA Info for this Regulation Number
Classification Product Code
DPS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/08/2001
Decision Date
02/06/2002
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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