BILI-THERAPY PAD TYPE— 510(k) K111547

Substantially Equivalent

Atom Medical Corporation

FDA 510(k) clearance K111547 for BILI-THERAPY PAD TYPE, Substantially Equivalent on 2012-04-12. 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: 2011-06-03
Decision date: 2012-04-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bonita Springs, 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.