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510(k) K843924

DIGITAL ELECTRONEUROMETER S-100 by Neurotron, Inc. — Product Code JXE

K843924 is an FDA 510(k) premarket notification submitted by Neurotron, Inc. for the device "DIGITAL ELECTRONEUROMETER S-100". The FDA issued a decision of Substantially Equivalent on March 12, 1985. The device falls under product code JXE (Device, Nerve Conduction Velocity Measurement), a Class II device regulated under 21 CFR 882.1550. Neurotron, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 1985
Date Received
October 5, 1984
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 Neurotron, Inc.

  • K853608 — NEUROMETER (June 12, 1986)

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)
  • K003508 — NC-STAT (January 17, 2001)

FDA data resources