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510(k) K102862

NEUROVISION SE (NERVEANA) by Neurovision Medical Products, Inc. — Product Code ETN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 21, 2010
Date Received
September 30, 2010
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 Neurovision Medical Products, Inc.

  • K130570 — NEUROVISION MEDICAL MOTION SENSOR (December 26, 2013)
  • K130806 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (July 12, 2013)
  • K113771 — SIGNAL GEAR URETHRAL CATHETER ELECTRODE (December 13, 2012)
  • K121931 — NONDISPOSABLE STIMULATING INSTRUMENTS (October 19, 2012)
  • K110989 — NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE (November 3, 2011)
  • K110140 — NEUROVISION NERVE LOCATOR MONITOR (September 30, 2011)
  • K110712 — DRYTOUCH SUCTION STIMULATOR PROBE (June 28, 2011)
  • K110138 — PAIRED HYDROGEL ELECTRODE (April 8, 2011)

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  • K232888 — Disposable Laryngeal Electrodes (December 21, 2023)
  • K230320 — NIM Standard Reinforced EMG Endotracheal Tube; CONTACT Reinforced EMG Endotrache (October 26, 2023)
  • K230853 — EARP Nerve Cuff Electrode (October 6, 2023)
  • K231580 — NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) (August 30, 2023)
  • K223254 — C2 Xplore (January 27, 2023)