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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
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