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510(k) K012069

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

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

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  • 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)