SREE MRI Transport Incubator

Incubator, Neonatal Transport

ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS

The following data is part of a premarket notification filed by Advanced Imaging Research Dba Sree Medical Systems with the FDA for Sree Mri Transport Incubator.

Pre-market Notification Details

Device IDK161918
510k NumberK161918
Device Name:SREE MRI Transport Incubator
ClassificationIncubator, Neonatal Transport
Applicant ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS PO BOX 603220 Cleveland,  OH  44103
ContactRavi Srinivasan
CorrespondentRavi Srinivasan
ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS PO BOX 603220 Cleveland,  OH  44103
Product CodeFPL  
CFR Regulation Number880.5410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-07-13
Decision Date2017-03-03
Summary:summary

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