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510(k) K130346

SYNERGY FOCUS DESKTOP VERSION; SYNERGY FOCUS LAPTOP VERSION by Natus Neurology Incorporated — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 2013
Date Received
February 11, 2013
Clearance Type
Special
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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Other clearances for product code GWF

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  • K242345 — Delphi Stimulator (November 5, 2024)
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  • K234080 — MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) (March 25, 2024)
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