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510(k) K242525

iTOF® by Nerbio Medical Software Platforms, Inc. — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 2024
Date Received
August 26, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Stimulator, Nerve, Peripheral, Electric
Device Class
Class II
Regulation Number
868.2775
Review Panel
AN
Submission Type

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  • K192958 — TwitchView System (April 2, 2020)
  • K190795 — Tetragraph Neuromuscular Transmission Monitor (October 18, 2019)
  • K172690 — ToFscan (May 31, 2018)