Vatech A9 (Model : PHT-30CSS)

X-ray, Tomography, Computed, Dental

Vatech Co., Ltd

The following data is part of a premarket notification filed by Vatech Co., Ltd with the FDA for Vatech A9 (model : Pht-30css).

Pre-market Notification Details

Device IDK203797
510k NumberK203797
Device Name:Vatech A9 (Model : PHT-30CSS)
ClassificationX-ray, Tomography, Computed, Dental
Applicant Vatech Co., Ltd 13, Samsung 1-ro 2-gil Hwaseong-si,  KR 18449
ContactDaniel Kim
CorrespondentDave Kim
Mtech Group 7707 Fannin St., Ste. 200-V111 Houston,  TX  77054
Product CodeOAS  
CFR Regulation Number892.1750 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-12-28
Decision Date2021-01-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08800016401103 K203797 000
08800016401097 K203797 000

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