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510(k) K001705

STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF by Chester Labs, Inc. — Product Code GYB

K001705 is an FDA 510(k) premarket notification submitted by Chester Labs, Inc. for the device "STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF". The FDA issued a decision of Substantially Equivalent on June 29, 2000. The device falls under product code GYB (Media, Electroconductive), a Class II device regulated under 21 CFR 882.1275. Chester Labs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 2000
Date Received
June 5, 2000
Clearance Type
Special
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 Chester Labs, Inc.

  • K041060 — E-Z LUBRICATING JELLY (May 7, 2004)
  • K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE (June 14, 2000)
  • K944598 — GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL (May 7, 1996)
  • K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY (May 7, 1996)
  • K944600 — GRAHAM-FIELD SALINE ELECTROLYTE GEL (November 20, 1995)
  • K944597 — GRAHAM-FIELD ULTRASOUND SCANNING GEL (June 21, 1995)
  • K944596 — GRAHAM-FIELD ULTRASOUND LOTION (June 7, 1995)
  • K940256 — BIOSHIELD BLUE LATEX GLOVES (March 23, 1994)
  • K940254 — BIOSHIELD BLUE POWDER FREE GLOVE (March 23, 1994)
  • K841871 — LIQUA-SONIC GEL (March 14, 1985)

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