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FDA 510(k)

neuromate Gen III

K-Number: K180206 · 2018-04-24

ApplicantRenishaw Mayfield Sarl
Decision Date2018-04-24
Product CodeHAW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

neuromate Gen III is a medical device manufactured by Renishaw Mayfield Sarl. It received FDA 510(k) clearance on 2018-04-24 under approval number K180206. The device is classified under product code HAW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the neuromate Gen III?

neuromate Gen III is a medical device that received FDA 510(k) clearance on 2018-04-24. It is manufactured by Renishaw Mayfield Sarl. The 510(k) number is K180206.

When was neuromate Gen III approved by the FDA?

neuromate Gen III received FDA 510(k) clearance on 2018-04-24, under approval number K180206.

What company makes neuromate Gen III?

neuromate Gen III is manufactured by Renishaw Mayfield Sarl.

What is the FDA product code for neuromate Gen III?

The FDA product code for neuromate Gen III is HAW.

Other Devices by Renishaw Mayfield Sarl

K181706neuromate Gen III

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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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