510(k) K241595

Device
EzVu Visual Vasopressor injector (EV-19)
Applicant
Veol Medical Technologies Pvt , Ltd.
510(k) number
K241595
Product code
FBK
Decision
Substantially Equivalent (SESE)
Decision date
2025-02-27
Date received
2024-06-03
Regulation
876.1500
Classification name
Endoscopic Injection Needle, Gastroenterology-Urology
Medical specialty
Gastroenterology, Urology
Review panel
Gastroenterology, Urology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Sneha Pandit
Address
A 747, Midc Pawane, Ttc Industrial Area, Kopar Khairane, Navi Mumbai IN 400705 400705

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code FBK

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