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Visionsense Stereoscopic Vision System (Vs System)

by Visionsense Ltd.

510(k) K082667

Visionsense Stereoscopic Vision System (Vs System) is a medical device (FDA Class II; FDA product code EOB, Nasopharyngoscope (Flexible Or Rigid)) made by Visionsense Ltd., cleared under FDA 510(k) K082667 on 30 Oct 2008, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK082667 Date30 Oct 2008ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
EOB
FDA applicant
Visionsense, Ltd.
Device class
Class II
Regulation
21 CFR Part 874.4760
Advisory committee
Ear, Nose, Throat
FDA decision
SESE Substantially Equivalent

Similar devices

Other devices filed under FDA product code EOB (Nasopharyngoscope (Flexible Or Rigid)).

Other devices from Visionsense Ltd.

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