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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Nerve, Peripheral, Electric
510(k) Number K242525
Device Name iTOF®
Applicant
Nerbio Medical Software Platforms, Inc.
1900 Camden Ave.
San Jose,  CA  95512
Applicant Contact Lloyd Leonard
Correspondent
Third Party Review Group, LLC
25 Independence Blvd.
Warren,  NJ  07059
Correspondent Contact Dave Yungvirt
Regulation Number868.2775
Classification Product Code
KOI  
Date Received08/26/2024
Decision Date 12/05/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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