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FDA 510(k) Application Details - K002817
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K002817
Device Name
Computer, Diagnostic, Programmable
Applicant
ELA MEDICAL, INC.
2950 XENIUM LN. NORTH, #120
PLYMOUTH, MN 55441 US
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Contact
SUSAN OLIVE
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
09/11/2000
Decision Date
05/02/2001
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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