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510(k) K242726

Synapsys VHIT by Inventis S.R.L. — Product Code GWN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 3, 2025
Date Received
September 10, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Nystagmograph
Device Class
Class II
Regulation Number
882.1460
Review Panel
NE
Submission Type

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  • K181771 — RightEye Vision System (September 28, 2018)
  • K182214 — DizzyDoctor System 1.0.0 (September 14, 2018)
  • K181025 — I-Portal Neuro Otologic Test Center; I-Portal Video Nystagmography System; I-Por (July 24, 2018)
  • K171884 — I-Portal Portable Assessment System - Nystagmograph (I-PAS) (November 22, 2017)