ExamVue Duo

System, X-ray, Stationary

JPI Healthcare Co, Ltd.

The following data is part of a premarket notification filed by Jpi Healthcare Co, Ltd. with the FDA for Examvue Duo.

Pre-market Notification Details

Device IDK213057
510k NumberK213057
Device Name:ExamVue Duo
ClassificationSystem, X-ray, Stationary
Applicant JPI Healthcare Co, Ltd. 608-Ho, 28, Digital-Ro 33-Gil, Guro-Gu Seoul,  KR 08377
ContactSam Kang
CorrespondentWilliam Little
JPI Healthcare Solutions, Inc 52 Newtown Plaza Plainview,  NY  11803
Product CodeKPR  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-22
Decision Date2022-02-18

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
08809413810679 K213057 000

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