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510(k) K931923

DANTEC MAGLITE MAGNETIC STIMULATOR (MAGLITE) by Dantec Medical, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 1993
Date Received
April 16, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Electrical, Evoked Response
Device Class
Class II
Regulation Number
882.1870
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)
  • K934580 — DANTEC 13R45 BAR ELECTRODE (September 26, 1994)
  • K931966 — DANTEC DISPOSABLE CONCENTRIC NEEDLE (March 30, 1994)
  • K926516 — DANTEC MAGNETIC STIMULATOR MAGPRO (August 31, 1993)

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