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FDA 510(k)

MAGNETOM ESSENZA

K-Number: K161795 · 2016-11-18

Decision Date2016-11-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAGNETOM ESSENZA is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2016-11-18 under approval number K161795. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAGNETOM ESSENZA?

MAGNETOM ESSENZA is a medical device that received FDA 510(k) clearance on 2016-11-18. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K161795.

When was MAGNETOM ESSENZA approved by the FDA?

MAGNETOM ESSENZA received FDA 510(k) clearance on 2016-11-18, under approval number K161795.

What company makes MAGNETOM ESSENZA?

MAGNETOM ESSENZA is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for MAGNETOM ESSENZA?

The FDA product code for MAGNETOM ESSENZA is LNH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.