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FDA 510(k), K181771, RightEye Vision System
FDA 510(k), K181771, RightEye Vision System
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510(K) Number: K181771
Device Name: RightEye Vision System
Manufacturer: Adam Gross
Device Classification Name: Nystagmograph
Regulation Number: GWN
Classification Product Code: KXA
Date Received: 07/03/2018
Decision Date: 09/28/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
Device Name: RightEye Vision System
Manufacturer: Adam Gross
Device Classification Name: Nystagmograph
Regulation Number: GWN
Classification Product Code: KXA
Date Received: 07/03/2018
Decision Date: 09/28/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Ophthalmic
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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