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FDA 510(k)

NIM Vital, Nerve Integrity Monitor

K-Number: K200759 · 2020-10-28

ApplicantMedtronic Xomed, Inc.
Decision Date2020-10-28
Product CodeGWF
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NIM Vital, Nerve Integrity Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2020-10-28 under 510(k) number K200759. The device is classified under product code GWF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIM Vital, Nerve Integrity Monitor?

NIM Vital, Nerve Integrity Monitor is a medical device that received FDA 510(k) clearance on 2020-10-28. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K200759.

When did NIM Vital, Nerve Integrity Monitor receive FDA 510(k) clearance?

NIM Vital, Nerve Integrity Monitor received FDA 510(k) clearance on 2020-10-28, under 510(k) number K200759.

Who is the listed applicant for NIM Vital, Nerve Integrity Monitor?

The FDA 510(k) record lists Medtronic Xomed, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NIM Vital, Nerve Integrity Monitor?

The FDA product code for NIM Vital, Nerve Integrity Monitor is GWF.

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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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