FDA 510(k) Application Details - K213699

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K213699
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Caretaker Medical, LLC 941 Glenwood Station Ln, Suite 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	11/23/2021
Decision Date	03/30/2022
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