INFANT ARRAY— 510(k) K113365

Name: FDA 510(k) clearance K113365
Creator: U.S. Food and Drug Administration
Published: 2012-03-29

Substantially Equivalent

Advanced Imaging Research Dba Sree Medical Systems

FDA 510(k) clearance K113365 for INFANT ARRAY, Substantially Equivalent on 2012-03-29. Applicant: Advanced Imaging Research Dba Sree Medical Systems. Device class: 2.

Clearance details

Applicant: Advanced Imaging Research Dba Sree Medical Systems
Product code: Code MOS
Device class: Class 2
Regulation: 21 CFR 892.1000
Advisory panel: Radiology
Date received: 2011-11-15
Decision date: 2012-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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