SREE MRI Transport Incubator
K-Number: K161918 · 2017-03-03
Decision Date2017-03-03
Product CodeFPL
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
SREE MRI Transport Incubator is a medical device manufactured by Advanced Imaging Research Dba Sree Medical Systems. It received FDA 510(k) clearance on 2017-03-03 under approval number K161918. The device is classified under product code FPL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SREE MRI Transport Incubator?
SREE MRI Transport Incubator is a medical device that received FDA 510(k) clearance on 2017-03-03. It is manufactured by Advanced Imaging Research Dba Sree Medical Systems. The 510(k) number is K161918.
When was SREE MRI Transport Incubator approved by the FDA?
SREE MRI Transport Incubator received FDA 510(k) clearance on 2017-03-03, under approval number K161918.
What company makes SREE MRI Transport Incubator?
SREE MRI Transport Incubator is manufactured by Advanced Imaging Research Dba Sree Medical Systems.
What is the FDA product code for SREE MRI Transport Incubator?
The FDA product code for SREE MRI Transport Incubator is FPL.
Related Devices (Code: FPL)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.