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FDA 510(k) Application Details - K211557
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K211557
Device Name
Computer, Diagnostic, Programmable
Applicant
Itamar Medical, Ltd.
9 Halamish Street
Caesarea 3088900 IL
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Contact
Moti Mikles
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
05/19/2021
Decision Date
12/29/2022
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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