Synapse Transcutaneous Electrical Stimulation Device— 510(k) K143198

Name: FDA 510(k) clearance K143198
Creator: U.S. Food and Drug Administration
Published: 2015-05-27

Substantially Equivalent

Synapse Electroceutical Limited

FDA 510(k) clearance K143198 for Synapse Transcutaneous Electrical Stimulation Device, Substantially Equivalent on 2015-05-27. Applicant: Synapse Electroceutical Limited. Device class: 2.

Clearance details

Applicant: Synapse Electroceutical Limited
Product code: Code GZJ
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2014-11-06
Decision date: 2015-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westerham, GB

Download summary PDF View on FDA.gov ↗

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