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510(k) K964622

MEDI-DX 7000 by Neuro-Diagnostic Assoc. — Product Code LLN

K964622 is an FDA 510(k) premarket notification submitted by Neuro-Diagnostic Assoc. for the device "MEDI-DX 7000". The FDA issued a decision of Substantially Equivalent on December 1, 1997. The device falls under product code LLN (Device, Vibration Threshold Measurement), a Class I device regulated under 21 CFR 882.1200. Neuro-Diagnostic Assoc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1997
Date Received
November 18, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Vibration Threshold Measurement
Device Class
Class I
Regulation Number
882.1200
Review Panel
NE
Submission Type

Other clearances by Neuro-Diagnostic Assoc.

  • K980866 — MEDI-DX 7000 CPT WITH AMREX ELECTRODES (May 20, 1998)

Other clearances for product code LLN

  • K072882 — PAIN VISION, MODEL PS-2100 (January 8, 2009)
  • K030829 — VPT METER (December 5, 2003)
  • K010981 — GSA GENITO SENSORY ANALYZER (September 20, 2001)
  • K964815 — AP-4000, AIR PULSE SENSORY STIMULATOR (September 4, 1997)
  • K970180 — VSA 3000 VIBRATORYN SENSORY ANALYZER (April 25, 1997)
  • K934368 — NK PRESSURE-SPECIFIED SENSORY DEVICE, MODEL PSSD-001 (August 11, 1994)
  • K921560 — VIBROTACTILE TESTER, MODEL NO. VTT-100 (October 30, 1992)
  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K872931 — TECA/MEDELEC TTT THERMAL THRESHOLD TESTER (November 16, 1987)
  • K863607 — VIBRATRON II, VIBRATION SENSITIVITY TESTER (December 3, 1986)

FDA data resources