Home / 510(k) Clearances / K012069

510(k) K012069

MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT by Neurotron Medical, Inc. — Product Code JXE

K012069 is an FDA 510(k) premarket notification submitted by Neurotron Medical, Inc. for the device "MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT". The FDA issued a decision of Substantially Equivalent on August 1, 2001. The device falls under product code JXE (Device, Nerve Conduction Velocity Measurement), a Class II device regulated under 21 CFR 882.1550. Neurotron Medical, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2001
Date Received
July 2, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Nerve Conduction Velocity Measurement
Device Class
Class II
Regulation Number
882.1550
Review Panel
NE
Submission Type

Other clearances by Neurotron Medical, Inc.

  • K053214 — THERAKNIT GARMENT ELECTRODE (December 20, 2005)
  • K963208 — NERVEPACE(R) NERVE CONDUCTION VIEWSCOPE (200VS) (July 14, 1997)

Other clearances for product code JXE

  • K240189 — NM-01/CPT neurometer (NM-01/CPT) (March 26, 2025)
  • K190536 — Mediracer NCS (September 25, 2019)
  • K070109 — NEUROMETRIX ADVANCE (April 25, 2008)
  • K060584 — NC-STAT (July 31, 2006)
  • K053058 — XLTEK NEUROPATH, MODEL PK1070 (February 7, 2006)
  • K052904 — VIRTUAL MEDICAL SYSTEMS MODEL VT3000 (October 27, 2005)
  • K041320 — MODIFICATION TO NC-STAT (August 12, 2004)
  • K013459 — MODIFICATION OF NC-STAT (January 17, 2002)
  • K003508 — NC-STAT (January 17, 2001)
  • K001692 — NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (November 24, 2000)

FDA data resources