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510(k) K820040

SC-IT IMPEDANCE TESTER by Cadwell Laboratories, Inc. — Product Code GYA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1982
Date Received
January 7, 1982
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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  • K946094 — CADWELL EASY AMBULATORY EEG (September 12, 1995)

Other clearances for product code GYA

  • K883869 — DERMTRODE (September 30, 1988)
  • K854396 — RUB E-Z (May 8, 1986)
  • K830877 — AP-CHECK (June 8, 1983)
  • K781475 — ELECTRODE IMPEDANCE TESTER-MODEL 500 (September 7, 1978)