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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 the device name listed in this FDA 510(k) record. The listed applicant is Hygieia, Inc.. It received FDA 510(k) clearance on 2019-02-04 under 510(k) 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. The listed applicant is Hygieia, Inc.. The 510(k) number is K181916.

When did d-Nav System receive FDA 510(k) clearance?

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

Who is the listed applicant for d-Nav System?

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

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

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

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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.

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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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