SREE MRI Transport Incubator— 510(k) K161918

Name: FDA 510(k) clearance K161918
Creator: U.S. Food and Drug Administration
Published: 2017-03-03

Substantially Equivalent

Advanced Imaging Research Dba Sree Medical Systems

FDA 510(k) clearance K161918 for SREE MRI Transport Incubator, Substantially Equivalent on 2017-03-03. Applicant: Advanced Imaging Research Dba Sree Medical Systems. Device class: 2.

Clearance details

Applicant: Advanced Imaging Research Dba Sree Medical Systems
Product code: Code FPL
Device class: Class 2
Regulation: 21 CFR 880.5410
Advisory panel: General Hospital
Date received: 2016-07-13
Decision date: 2017-03-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cleveland, OH, US

Download summary PDF View on FDA.gov ↗

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