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FDA 510(k) Application Details - K213861
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K213861
Device Name
Computer, Diagnostic, Programmable
Applicant
CardioCalm Srl
Via Martiri della Liberta, nr. 40
Montichiari 25018 IT
Other 510(k) Applications for this Company
Contact
Fabio Badilini
Other 510(k) Applications for this Contact
Regulation Number
870.1425
More FDA Info for this Regulation Number
Classification Product Code
DQK
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/10/2021
Decision Date
04/25/2022
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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