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510(k) K090838

STIMULUS/DISSECTION INSTRUMENTS by Axon Systems, Inc. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 20, 2009
Date Received
March 27, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve
Device Class
Class II
Regulation Number
874.1820
Review Panel
EN
Submission Type

Other clearances by Axon Systems, Inc.

  • 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)
  • K002316 — PHOENIX DIGITAL EEG (October 26, 2000)

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