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510(k) K130806

NEUROVISION INK PRINTED ENDOTRACHEAL TUBE ELECTRODE by Neurovision Medical Products, Inc. — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 2013
Date Received
March 25, 2013
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Nerve Locator
Device Class
Class II
Regulation Number
874.1820
Review Panel
NE
Submission Type

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

Other clearances by Neurovision Medical Products, Inc.

  • K130570 — NEUROVISION MEDICAL MOTION SENSOR (December 26, 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)
  • K102862 — NEUROVISION SE (NERVEANA) (December 21, 2010)

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