FDA 510(k) Application Details - K201332

Device Classification Name	System, Measurement, Blood-Pressure, Non-Invasive   More FDA Info for this Device
510(K) Number	K201332
Device Name	System, Measurement, Blood-Pressure, Non-Invasive
Applicant	Meditech Ltd. 24 Mikszath Kalman utca Budapest 1184 HU Other 510(k) Applications for this Company
Contact	Gabor Kazi 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	05/19/2020
Decision Date	02/10/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review