EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001— 510(k) K051631

Name: FDA 510(k) clearance K051631
Creator: U.S. Food and Drug Administration
Published: 2005-07-27

Substantially Equivalent

Stargate International, Inc.

FDA 510(k) clearance K051631 for EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001, Substantially Equivalent on 2005-07-27. Applicant: Stargate International, Inc.. Device class: 2.

Clearance details

Applicant: Stargate International, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2005-06-20
Decision date: 2005-07-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parker, CO, US

Download summary PDF View on FDA.gov ↗

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