FDA.report

510(k) K222735

Device
HJY VisualNext Endoscopic Vision System
Applicant
Hjy Smart Medical Device Co., Ltd.
510(k) number
K222735
Product code
GWG
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-28
Date received
2022-09-09
Regulation
882.1480
Classification name
Endoscope, Neurological
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
John Jiannyuh Chen
Address
12f., # 415, Sec. 4, Xinyi Dist. Taipei City TW 11051 11051

FDA Registration Numbers

Source Documents

510(k) summary PDF

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