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FDA 510(k)

d-Nav System

K-Number: K181916 · 2019-02-04

ApplicantHygieia, Inc.
Decision Date2019-02-04
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

d-Nav System is a medical device manufactured by Hygieia, Inc.. It received FDA 510(k) clearance on 2019-02-04 under approval number K181916. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the d-Nav System?

d-Nav System is a medical device that received FDA 510(k) clearance on 2019-02-04. It is manufactured by Hygieia, Inc.. The 510(k) number is K181916.

When was d-Nav System approved by the FDA?

d-Nav System received FDA 510(k) clearance on 2019-02-04, under approval number K181916.

What company makes d-Nav System?

d-Nav System is manufactured by Hygieia, Inc..

What is the FDA product code for d-Nav System?

The FDA product code for d-Nav System is NDC.

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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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