FDA 510(k)

Navik 3D

K-Number: K152160 · 2016-02-23

Decision Date2016-02-23

Product CodeDQK

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Navik 3D is the device name listed in this FDA 510(k) record. The listed applicant is Apn Health, LLC. It received FDA 510(k) clearance on 2016-02-23 under 510(k) number K152160. The device is classified under product code DQK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Navik 3D?

Navik 3D is a medical device that received FDA 510(k) clearance on 2016-02-23. The listed applicant is Apn Health, LLC. The 510(k) number is K152160.

When did Navik 3D receive FDA 510(k) clearance?

Navik 3D received FDA 510(k) clearance on 2016-02-23, under 510(k) number K152160.

Who is the listed applicant for Navik 3D?

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

What is the FDA product code for Navik 3D?

The FDA product code for Navik 3D is DQK.

Related Devices (Code: DQK)

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.

K253576CorVista System® with PCWP Add-OnAnalytics For Life, Inc.K262006EnSite™ X EP SystemAbbott Medical K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC K253463ILR ECG Analyzer (IM007)Implicity, Inc.K261119NorthStar Mapping System (MAP01 or MAP01-01)Imricor Medical Systems, Inc.K253088OneStim-DUO Cardiac Stimulator (MP5003-4CO)Micropace Pty, Ltd.

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.