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FDA 510(k)

Neuro Assessment System NAS-1000

K-Number: K172892 · 2018-03-08

ApplicantHeadsense Medical, Inc.
Decision Date2018-03-08
Product CodeQBE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Neuro Assessment System NAS-1000 is the device name listed in this FDA 510(k) record. The listed applicant is Headsense Medical, Inc.. It received FDA 510(k) clearance on 2018-03-08 under 510(k) number K172892. The device is classified under product code QBE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Neuro Assessment System NAS-1000?

Neuro Assessment System NAS-1000 is a medical device that received FDA 510(k) clearance on 2018-03-08. The listed applicant is Headsense Medical, Inc.. The 510(k) number is K172892.

When did Neuro Assessment System NAS-1000 receive FDA 510(k) clearance?

Neuro Assessment System NAS-1000 received FDA 510(k) clearance on 2018-03-08, under 510(k) number K172892.

Who is the listed applicant for Neuro Assessment System NAS-1000?

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

What is the FDA product code for Neuro Assessment System NAS-1000?

The FDA product code for Neuro Assessment System NAS-1000 is QBE.

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.

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