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FDA 510(k) Application Details - K993620
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K993620
Device Name
Computer, Diagnostic, Programmable
Applicant
DEL MAR MEDICAL SYSTEMS, LLC.
1621 ALTON PKWY.
IRVINE, CA 92606 US
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Contact
NEVINE ERIAN
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/26/1999
Decision Date
11/12/1999
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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