V20, V20a, AVSM3 SNF

System, Measurement, Blood-pressure, Non-invasive

Mediana Co., Ltd.

The following data is part of a premarket notification filed by Mediana Co., Ltd. with the FDA for V20, V20a, Avsm3 Snf.

Pre-market Notification Details

Device IDK200434
510k NumberK200434
Device Name:V20, V20a, AVSM3 SNF
ClassificationSystem, Measurement, Blood-pressure, Non-invasive
Applicant Mediana Co., Ltd. 132, Donghwagongdan-ro, Munmak-eup Wonju-si,  KR 26365
ContactDana Mun
CorrespondentCharlie Mack
International Regulatory Consultants 2950 E Lindrick Drive Chandler,  AZ  85249
Product CodeDXN  
Subsequent Product CodeDQA
Subsequent Product CodeFLL
CFR Regulation Number870.1130 [🔎]
DecisionSubstantially Equivalent (SESE)
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-24
Decision Date2020-10-09

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