ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE— 510(k) K113375

Name: FDA 510(k) clearance K113375
Creator: U.S. Food and Drug Administration
Published: 2013-01-25

Substantially Equivalent

Eswallow USA

FDA 510(k) clearance K113375 for ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE, Substantially Equivalent on 2013-01-25. Applicant: Eswallow USA. Device class: 2.

Clearance details

Applicant: Eswallow USA
Product code: Code GXY
Device class: Class 2
Regulation: 21 CFR 882.1320
Advisory panel: Neurology
Date received: 2011-11-16
Decision date: 2013-01-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guntersville, AL, US

Download summary PDF View on FDA.gov ↗

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