510(k) K172690

ToFscan by Idmed — Product Code KOI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 31, 2018
Date Received
September 6, 2017
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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