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510(k) K970943

GUIDELINE SYSTEM by Axon Instruments, Inc. — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 18, 1997
Date Received
March 14, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Depth
Device Class
Class II
Regulation Number
882.1330
Review Panel
NE
Submission Type

Other clearances by Axon Instruments, Inc.

  • K990683 — AXON MP-1 MICROPOSITIONER (November 3, 1999)
  • K971318 — MM-1 MOVEMENT MONITOR (July 28, 1997)

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