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510(k) K934580

DANTEC 13R45 BAR ELECTRODE by Dantec Medical, Inc. — Product Code GXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1994
Date Received
September 23, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Cutaneous
Device Class
Class II
Regulation Number
882.1320
Review Panel
NE
Submission Type

Other clearances by Dantec Medical, Inc.

  • K960503 — DANTEC DUET (September 16, 1996)
  • K950314 — DANTEC MONOPOLAR LUMEN ELECTRODE (13R18 AND 13R19) (March 25, 1996)
  • K953999 — DANTEC DA CAPO (November 21, 1995)
  • K926363 — MULTI-DOP S (June 19, 1995)
  • K931801 — MULTI-DOP X (June 14, 1995)
  • K930458 — MULTI-DOP L (February 3, 1995)
  • K932059 — NEEDLE ELECTRODES AND DISPOSABLE SCALP ELECTRODE (October 4, 1994)
  • K931966 — DANTEC DISPOSABLE CONCENTRIC NEEDLE (March 30, 1994)
  • K931923 — DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) (November 9, 1993)
  • K926516 — DANTEC MAGNETIC STIMULATOR MAGPRO (August 31, 1993)

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