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510(k) K904165

SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT by Occupational Preventive Diagnostics, Inc. — Product Code JXE

K904165 is an FDA 510(k) premarket notification submitted by Occupational Preventive Diagnostics, Inc. for the device "SENSORY NERVE CONDUCTION VELOCITY TESTING UNIT". The FDA issued a decision of Substantially Equivalent on May 28, 1991. 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
May 28, 1991
Date Received
September 11, 1990
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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  • 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