Erchonia FX-635— 510(k) K180197

Substantially Equivalent

Erchonia Corporation

FDA 510(k) clearance K180197 for Erchonia FX-635, Substantially Equivalent on 2018-05-21. Applicant: Erchonia Corporation. Device class: 2.

Clearance details

Applicant: Erchonia Corporation
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2018-01-24
Decision date: 2018-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Melbourne, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.