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FDA 510(k) Application Details - K230008
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K230008
Device Name
Computer, Diagnostic, Programmable
Applicant
Ablacon, Inc.
4800 Wadsworth Blvd. Suite 310
Denver, CO 80033 US
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Contact
Frank Rodrigues
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
01/03/2023
Decision Date
06/08/2023
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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