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510(k) K923665

REUSABLE DUAL DISC BAR RECORDING ELECTRODES by Chalgren Enterprises, Inc. — Product Code JXE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
July 22, 1992
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 Chalgren Enterprises, Inc.

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  • K953356 — EMG RECORDING RING ELECTRODE (January 22, 1996)
  • K953354 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K953361 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K952908 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K952690 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K953887 — RE-USABLE CONCENTRIC NEEDLE (October 31, 1995)
  • K953886 — RE-USABLE MONOPOLAR NEEDLE (October 31, 1995)

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