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510(k) K935298

INSTA-NERVE(TM) NERVE CONDUCTION MONITOR by Insta Nerve Canada, Inc. — Product Code JXE

K935298 is an FDA 510(k) premarket notification submitted by Insta Nerve Canada, Inc. for the device "INSTA-NERVE(TM) NERVE CONDUCTION MONITOR". The FDA issued a decision of Substantially Equivalent on August 3, 1994. The device falls under product code JXE (Device, Nerve Conduction Velocity Measurement), a Class II device regulated under 21 CFR 882.1550.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1994
Date Received
November 2, 1993
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

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  • 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