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510(k) K212166

ISIS Headboxes, ISIS Neurostimulator, ISIS Xpert Plus, ISIS Xpert, ISIS Xpress by Inomed Medizintechnik GmbH — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 2022
Date Received
July 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
Review Panel
NE
Submission Type

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  • K091874 — INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 (November 18, 2009)
  • K042208 — ISIS MER SYSTEM/ELEKTA MER SYSTEM (March 18, 2005)
  • K910972 — WALTER GRAPHTEK (October 2, 1991)

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