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510(k) K854396

RUB E-Z by E-Z Instruments Co. — Product Code GYA

K854396 is an FDA 510(k) premarket notification submitted by E-Z Instruments Co. for the device "RUB E-Z". The FDA issued a decision of Substantially Equivalent on May 8, 1986. The device falls under product code GYA (Tester, Electrode/Lead, Electroencephalograph), a Class I device regulated under 21 CFR 882.1410.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 1986
Date Received
October 31, 1985
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

Other clearances for product code GYA

  • K883869 — DERMTRODE (September 30, 1988)
  • K830877 — AP-CHECK (June 8, 1983)
  • K820040 — SC-IT IMPEDANCE TESTER (January 28, 1982)
  • K781475 — ELECTRODE IMPEDANCE TESTER-MODEL 500 (September 7, 1978)

FDA data resources