NicoletOne
K-Number: K173366 · 2018-07-20
ApplicantNatus Neurology Incorporated
Decision Date2018-07-20
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
NicoletOne is a medical device manufactured by Natus Neurology Incorporated. It received FDA 510(k) clearance on 2018-07-20 under approval 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. It is manufactured by Natus Neurology Incorporated. The 510(k) number is K173366.
When was NicoletOne approved by the FDA?
NicoletOne received FDA 510(k) clearance on 2018-07-20, under approval number K173366.
What company makes NicoletOne?
NicoletOne is manufactured by Natus Neurology Incorporated.
What is the FDA product code for NicoletOne?
The FDA product code for NicoletOne is OLZ.
Other Devices by Natus Neurology Incorporated
Related Devices (Code: OLZ)
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.