FDA.report

510(k) K250753

Device
VELMENI for DENTISTS (V4D)
Applicant
Velmeni, Inc.
510(k) number
K250753
Product code
MYN
Decision
Substantially Equivalent (SESE)
Decision date
2025-09-02
Date received
2025-03-12
Regulation
892.2070
Classification name
Analyzer, Medical Image
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Ishveen Anand
Address
333 W. Maude Ave. , Suite 207 Sunnyvale CA US 94085 94085

FDA Registration Numbers

Source Documents

510(k) summary PDF

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