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510(k) K980866

MEDI-DX 7000 CPT WITH AMREX ELECTRODES by Neuro-Diagnostic Assoc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 20, 1998
Date Received
February 19, 1998
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

Other clearances by Neuro-Diagnostic Assoc.

  • K964622 — MEDI-DX 7000 (December 1, 1997)

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