FDA 510(k)

NICO BrainPath

K-Number: K172433 · 2017-09-07

Decision Date2017-09-07

Product CodeGZT

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

NICO BrainPath is the device name listed in this FDA 510(k) record. The listed applicant is Nico Corporation. It received FDA 510(k) clearance on 2017-09-07 under 510(k) number K172433. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NICO BrainPath?

NICO BrainPath is a medical device that received FDA 510(k) clearance on 2017-09-07. The listed applicant is Nico Corporation. The 510(k) number is K172433.

When did NICO BrainPath receive FDA 510(k) clearance?

NICO BrainPath received FDA 510(k) clearance on 2017-09-07, under 510(k) number K172433.

Who is the listed applicant for NICO BrainPath?

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

What is the FDA product code for NICO BrainPath?

The FDA product code for NICO BrainPath is GZT.

Other records listing Nico Corporation 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.

K232567Myriad SPECTRA Light Source K191599NICO Myriad NOVUS K182340NICO Myriad K161307NICO Myriad K162075NICO TRIOwand

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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.