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510(k) K944061

CUEVA CRANIAL NERVE ELECTRODE by Ad-Tech Medical Instrument Corp — Product Code GZL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1995
Date Received
August 19, 1994
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

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  • K053358 — DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTROD (May 25, 2006)
  • K041604 — MACRO-MICRO DEPTH ELECTRODE (August 16, 2004)
  • K990788 — AD-TECH'S FORAMEN OVALE ELECTRODE (November 2, 1999)
  • K992194 — CORTICAL MAPPING UNIT, MODEL CMU (September 13, 1999)
  • K973454 — AD-TECH'S SPINAL ELECTRODE (June 10, 1998)
  • K964644 — AD-TECH'S DEPTH ELECTRODE (May 9, 1997)
  • K970587 — AD-TECH SUBDURAL ELECTRODE (May 9, 1997)
  • K940320 — AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS (September 19, 1995)

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