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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 the device name listed in this FDA 510(k) record. The listed applicant is Mipm Mammendorfer Institut Fur Physik Und Medizin. It received FDA 510(k) clearance on 2016-06-28 under 510(k) 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. The listed applicant is Mipm Mammendorfer Institut Fur Physik Und Medizin. The 510(k) number is K153739.

When did MRI Patient Monitor TeslaDUO receive FDA 510(k) clearance?

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

Who is the listed applicant for MRI Patient Monitor TeslaDUO?

The FDA 510(k) record lists Mipm Mammendorfer Institut Fur Physik Und Medizin as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: MWI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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