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510(k) K812284

ZEE ELECTRODE-GEL by Zee Medical Products Co., Inc. — Product Code GYB

K812284 is an FDA 510(k) premarket notification submitted by Zee Medical Products Co., Inc. for the device "ZEE ELECTRODE-GEL". The FDA issued a decision of Substantially Equivalent on September 8, 1981. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Zee Medical Products Co., Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 8, 1981
Date Received
August 13, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media, Electroconductive
Device Class
Class II
Regulation Number
882.1275
Review Panel
NE
Submission Type

Other clearances by Zee Medical Products Co., Inc.

  • K823501 — ZEE SPHYGMOMANOMETER (January 21, 1983)
  • K813156 — ULTRA-WIDE SAFETY SPECTACLE FRAME (December 14, 1981)
  • K813016 — ZEE TRACTION SPLINT (November 24, 1981)
  • K812814 — ZEE SURGICAL INSTRUMENTS (November 6, 1981)
  • K812564 — ZEE LIFE SUPPORT AIR PANTS (October 23, 1981)
  • K812342 — ZEE EXTRICATION DEVICE (September 21, 1981)
  • K812022 — ZEE MANUAL RESUSCITATOR (July 31, 1981)

Other clearances for product code GYB

  • K243749 — Jmoon Conductive Gel (April 8, 2025)
  • K220735 — Avologi Gel Primer (Model: Av25) (September 15, 2023)
  • K222770 — Conductive Gel (December 13, 2022)
  • K221724 — Conductive Gel (September 23, 2022)
  • K212325 — EEG-acp (June 15, 2022)
  • K212326 — AC Cream - Conductive paste (December 1, 2021)
  • K212787 — GT5 conductive & abrasive gel (November 8, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K191975 — Elefix V Paste for EEG & EMG (February 7, 2020)
  • K192606 — SAC2 - Electrode Cream (January 17, 2020)

FDA data resources