FDA.report

510(k) K233391

Device
cCeLL - In vivo
Applicant
VPIX Medical, Inc.
510(k) number
K233391
Product code
GWG
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-21
Date received
2023-10-02
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
Kyungmin Hwang
Address
774, Gyeryong-Ro, Jung-Gu Daejeon KR 34873 34873

FDA Registration Numbers

Source Documents

510(k) summary PDF

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