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FDA 510(k)

MRI Patient Monitor TeslaDUO

K-Number: K153739 · 2016-06-28

ApplicantMipm Mammendorfer Institut Fur Physik Und Medizin
Decision Date2016-06-28
Product CodeMWI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MRI Patient Monitor TeslaDUO is a medical device manufactured by Mipm Mammendorfer Institut Fur Physik Und Medizin. It received FDA 510(k) clearance on 2016-06-28 under approval number K153739. The device is classified under product code MWI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MRI Patient Monitor TeslaDUO?

MRI Patient Monitor TeslaDUO is a medical device that received FDA 510(k) clearance on 2016-06-28. It is manufactured by Mipm Mammendorfer Institut Fur Physik Und Medizin. The 510(k) number is K153739.

When was MRI Patient Monitor TeslaDUO approved by the FDA?

MRI Patient Monitor TeslaDUO received FDA 510(k) clearance on 2016-06-28, under approval number K153739.

What company makes MRI Patient Monitor TeslaDUO?

MRI Patient Monitor TeslaDUO is manufactured by Mipm Mammendorfer Institut Fur Physik Und Medizin.

What is the FDA product code for MRI Patient Monitor TeslaDUO?

The FDA product code for MRI Patient Monitor TeslaDUO is MWI.

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Official Source

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