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510(k) K921504

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 11, 1992
Date Received
March 31, 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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  • K960591 — RE-USABLE BIPOLAR CONCENTRIC NEEDLE(237-XXX-24,237-XXX-24STP, 237-XXX-24TP,237-X (June 13, 1996)
  • K955335 — DISPOSABLE HYPODERMIC MONOPOLAR NEEDLE RECORDING ELECTRODE (January 29, 1996)
  • K953361 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K953356 — EMG RECORDING RING ELECTRODE (January 22, 1996)
  • K953354 — EMG DISC RECORDING ELECTRODE (January 22, 1996)
  • K952690 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K952908 — EMG DISC RECORDING ELECTRODE WITH PIN (December 6, 1995)
  • K953886 — RE-USABLE MONOPOLAR NEEDLE (October 31, 1995)
  • K953887 — RE-USABLE CONCENTRIC NEEDLE (October 31, 1995)

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  • K003508 — NC-STAT (January 17, 2001)