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510(k) K830877

AP-CHECK by General Devices — Product Code GYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 1983
Date Received
March 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Electrode/Lead, Electroencephalograph
Device Class
Class I
Regulation Number
882.1410
Review Panel
NE
Submission Type

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  • K912008 — TRU-VIEW MULTI-CHANNEL DISPLAY (October 9, 1991)
  • K896153 — MODIFIED DR-2C/PMC 100 (January 19, 1990)
  • K862596 — DR-2C (MODIFICATION) (September 26, 1986)

Other clearances for product code GYA

  • K883869 — DERMTRODE (September 30, 1988)
  • K854396 — RUB E-Z (May 8, 1986)
  • K820040 — SC-IT IMPEDANCE TESTER (January 28, 1982)
  • K781475 — ELECTRODE IMPEDANCE TESTER-MODEL 500 (September 7, 1978)