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510(k) K003508

NC-STAT by Neurometrix, Inc. — Product Code JXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 17, 2001
Date Received
November 14, 2000
Clearance Type
Traditional
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 Neurometrix, Inc.

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  • K152954 — Quell (January 5, 2016)
  • K140586 — ASCEND ELECTRODE (November 17, 2014)
  • K140333 — ASCEND (July 3, 2014)
  • K130919 — SENSUS (July 2, 2013)
  • K121816 — SENSUS ELECTRODE (November 26, 2012)
  • K121184 — SENSUS (August 2, 2012)
  • K091155 — ASCEND (September 3, 2009)
  • K083322 — NEUROMETRIX BIOAMPLIFIER (May 27, 2009)
  • K083818 — UNIVERSAL ELECTRODES (January 21, 2009)

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)
  • K012069 — MODIFICATION TO:BREVIO NERVE CONDUCTION TEST INSTRUMENT (August 1, 2001)
  • K001692 — NEURO SCAN MEDICAL STSTEMS, MODEL MEDICOR 8 (November 24, 2000)