GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL— 510(k) K944598

Name: FDA 510(k) clearance K944598
Creator: U.S. Food and Drug Administration
Published: 1996-05-07

Substantially Equivalent

Chester Labs, Inc.

FDA 510(k) clearance K944598 for GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, Substantially Equivalent on 1996-05-07. Applicant: Chester Labs, Inc.. Device class: 2.

Clearance details

Applicant: Chester Labs, Inc.
Product code: Code GYB
Device class: Class 2
Regulation: 21 CFR 882.1275
Advisory panel: Neurology
Date received: 1994-09-19
Decision date: 1996-05-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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K001593 — MODIFICATION TO STATSIGN SALINE ELECTROLYTE GEL, GRAHAM-FIELD SALINE ELECTROLYTE GEL2000-06-14
K944599 — GRAHAM-FIELD CONDUCTIVE ECG SPRAY1996-05-07
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