FDA 510(k)

neuromate Gen III

K-Number: K181706 · 2018-07-26

Decision Date2018-07-26

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

neuromate Gen III is the device name listed in this FDA 510(k) record. The listed applicant is Renishaw Mayfield Sarl. It received FDA 510(k) clearance on 2018-07-26 under 510(k) number K181706. 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 2018-07-26. The listed applicant is Renishaw Mayfield Sarl. The 510(k) number is K181706.

When did neuromate Gen III receive FDA 510(k) clearance?

neuromate Gen III received FDA 510(k) clearance on 2018-07-26, under 510(k) number K181706.

Who is the listed applicant for neuromate Gen III?

The FDA 510(k) record lists Renishaw Mayfield Sarl as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for neuromate Gen III?

The FDA product code for neuromate Gen III is HAW.

Other records listing Renishaw Mayfield Sarl as applicant

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.

K180206neuromate Gen III

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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.