BILI-THERAPY SPOT TYPE— 510(k) K103828

Name: FDA 510(k) clearance K103828
Creator: U.S. Food and Drug Administration
Published: 2011-03-29

Substantially Equivalent

Atom Medical Corporation

FDA 510(k) clearance K103828 for BILI-THERAPY SPOT TYPE, Substantially Equivalent on 2011-03-29. Applicant: Atom Medical Corporation. Device class: 2.

Clearance details

Applicant: Atom Medical Corporation
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2010-12-28
Decision date: 2011-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, FL, US

Download summary PDF View on FDA.gov ↗

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