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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, measurement, blood-pressure, non-invasive
510(k) Number K201332
Device Name Meditech ABPM-06 (BP6)
Meditech Ltd.
24 Mikszath Kalman utca
Budapest,  HU 1184
Applicant Contact Gabor Kazi
Arazy Group Consultants Inc.
3422 Leonardo Lane
New Smyrna Beach,  FL  32168
Correspondent Contact Ray Kelly
Regulation Number870.1130
Classification Product Code
Date Received05/19/2020
Decision Date 02/10/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No