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510(k) K992194

CORTICAL MAPPING UNIT, MODEL CMU by Ad-Tech Medical Instrument Corp — Product Code GYC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 1999
Date Received
June 29, 1999
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cortical
Device Class
Class II
Regulation Number
882.1310
Review Panel
NE
Submission Type

Other clearances by Ad-Tech Medical Instrument Corp

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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)
  • 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)
  • K944061 — CUEVA CRANIAL NERVE ELECTRODE (January 20, 1995)

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