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510(k) K933796

EEG NEEDLE ELECTRODE by Cadwell Laboratories, Inc. — Product Code GXZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1994
Date Received
August 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Needle
Device Class
Class II
Regulation Number
882.1350
Review Panel
NE
Submission Type

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  • K962455 — FOUR-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K962457 — TWO-CHANNEL PREAMPLIFIER (January 13, 1997)
  • K946094 — CADWELL EASY AMBULATORY EEG (September 12, 1995)

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