FDA 510(k) Application Details - K211588

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K211588
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Caretaker Medical 941 Glenwood Station Ln #301 Charlottesville, VA 22901 US Other 510(k) Applications for this Company
Contact	Jeff Pompeo Other 510(k) Applications for this Contact
Regulation Number	870.1130   More FDA Info for this Regulation Number
Classification Product Code	DXN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/24/2021
Decision Date	08/13/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
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