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510(k) K971819

EPOCH 2000 NEUROLOGICAL WORKSTATION by Axon Systems, Inc. — Product Code GWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 1997
Date Received
May 16, 1997
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 Axon Systems, Inc.

  • K090838 — STIMULUS/DISSECTION INSTRUMENTS (July 20, 2009)
  • K062996 — DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES (January 12, 2007)
  • K062198 — SUNSPOTS PRE-GELLED SURFACE ELECTRODES (December 19, 2006)
  • K061639 — ECLIPSE TCD NEUROVASCULAR WORKSTATION; ELCLIPSE NEUROLOGICAL WORKSTATION WITH TC (November 1, 2006)
  • K061113 — ORTHOMON (May 23, 2006)
  • K050798 — ECLIPSE NEUROLOGICAL WORKSTATION (August 15, 2005)
  • K050194 — AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES (April 26, 2005)
  • K032741 — EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION (December 16, 2003)
  • K022785 — EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION (October 9, 2002)
  • K010697 — UNIQUE AMBULATORY EEG (June 6, 2001)

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