STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF— 510(k) K001705

Name: FDA 510(k) clearance K001705
Creator: U.S. Food and Drug Administration
Published: 2000-06-29

Substantially Equivalent

Chester Labs, Inc.

FDA 510(k) clearance K001705 for STATSIGN ELECTRODE CONDUCTIVITY GEL, GRAHAM-FIELD ELECTRODE CONDUCTIVITY GEL, MODELS 004008, 48-4000 2GF, 48-4000GF, Substantially Equivalent on 2000-06-29. 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: 2000-06-05
Decision date: 2000-06-29
Decision: Substantially Equivalent
Clearance type: Special
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

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