Meditech ABPM-06 (BP6)

System, Measurement, Blood-pressure, Non-invasive

Meditech Ltd.

The following data is part of a premarket notification filed by Meditech Ltd. with the FDA for Meditech Abpm-06 (bp6).

Pre-market Notification Details

Device IDK201332
510k NumberK201332
Device Name:Meditech ABPM-06 (BP6)
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Meditech Ltd. 24 Mikszath Kalman Utca Budapest,  HU 1184
ContactGabor Kazi
CorrespondentRay Kelly
Arazy Group Consultants Inc. 3422 Leonardo Lane New Smyrna Beach,  FL  32168
Product CodeDXN  
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-19
Decision Date2021-02-10

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