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FDA 510(k) Application Details - K201181
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K201181
Device Name
Computer, Diagnostic, Programmable
Applicant
Abbott Medical
5050 Nathan Lane North
Nathan Lane North, MN 55442 US
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Contact
Charlie Pickrell
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
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More FDA Info for this Product Code
Date Received
04/30/2020
Decision Date
06/26/2020
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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