510(k) K254133

Device
ENTity USB Videoscope System
Applicant
Optim, LLC
510(k) number
K254133
Product code
EOB
Decision
Substantially Equivalent (SESE)
Decision date
2026-05-14
Date received
2025-12-22
Regulation
874.4760
Classification name
Nasopharyngoscope (Flexible Or Rigid)
Medical specialty
Ear, Nose, Throat
Review panel
Ear, Nose, Throat
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Sheldon Sillyman
Address
64 Technology Park Rd. Sturbridge MA US 01566 01566

FDA Registration Numbers

Source Documents

510(k) summary PDF

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