ERCHONIA EMERGE— 510(k) K130996

Substantially Equivalent

Erchonia Medical, Inc.

FDA 510(k) clearance K130996 for ERCHONIA EMERGE, Substantially Equivalent on 2013-09-16. Applicant: Erchonia Medical, Inc.. Device class: 2.

Clearance details

Applicant: Erchonia Medical, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2013-04-10
Decision date: 2013-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Littleton, CO, 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.