ADD

Solid State X-ray Imager (flat Panel/digital Imager)

H&abyz Co., Ltd.

The following data is part of a premarket notification filed by H&abyz Co., Ltd. with the FDA for Add.

Pre-market Notification Details

Device IDK203188
510k NumberK203188
Device Name:ADD
ClassificationSolid State X-ray Imager (flat Panel/digital Imager)
Applicant H&abyz Co., Ltd. 1F, 2-Dong, 41-16 Cheoinseong-Ro, Namsa-Myeon, Cheoin-Gu Yongin-si,  KR 17118
ContactNamkyu Hur
CorrespondentIm Do Gyun
GMS Consulting Co., Ltd. 34, Sangamsan-ro, Mapo-gu Seoul,  KR 03909
Product CodeMQB  
CFR Regulation Number892.1680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-10-27
Decision Date2021-03-12

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