FDA 510(k)

neuro inspire

K-Number: K163666 · 2017-09-15

Decision Date2017-09-15

Product CodeHAW

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

neuro inspire is the device name listed in this FDA 510(k) record. The listed applicant is Rensihaw Plc. It received FDA 510(k) clearance on 2017-09-15 under 510(k) number K163666. 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 neuro inspire?

neuro inspire is a medical device that received FDA 510(k) clearance on 2017-09-15. The listed applicant is Rensihaw Plc. The 510(k) number is K163666.

When did neuro inspire receive FDA 510(k) clearance?

neuro inspire received FDA 510(k) clearance on 2017-09-15, under 510(k) number K163666.

Who is the listed applicant for neuro inspire?

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

What is the FDA product code for neuro inspire?

The FDA product code for neuro inspire is HAW.

Related Devices (Code: HAW)

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

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