FDA 510(k)

NicoletOne

K-Number: K173366 · 2018-07-20

Decision Date2018-07-20

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NicoletOne is the device name listed in this FDA 510(k) record. The listed applicant is Natus Neurology Incorporated. It received FDA 510(k) clearance on 2018-07-20 under 510(k) number K173366. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NicoletOne?

NicoletOne is a medical device that received FDA 510(k) clearance on 2018-07-20. The listed applicant is Natus Neurology Incorporated. The 510(k) number is K173366.

When did NicoletOne receive FDA 510(k) clearance?

NicoletOne received FDA 510(k) clearance on 2018-07-20, under 510(k) number K173366.

Who is the listed applicant for NicoletOne?

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

What is the FDA product code for NicoletOne?

The FDA product code for NicoletOne is OLZ.

Other records listing Natus Neurology Incorporated 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.

K243982Nicolet EDX K243495Natus Ultrapro S100 (982A0594)K172743Natus VikingQuest

Related Devices (Code: OLZ)

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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.