FDA 510(k)

Nox Sleep System

K-Number: K192469 · 2019-11-13

Decision Date2019-11-13

Product CodeOLZ

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

Nox Sleep System is the device name listed in this FDA 510(k) record. The listed applicant is Nox Medical. It received FDA 510(k) clearance on 2019-11-13 under 510(k) number K192469. The device is classified under product code OLZ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Nox Sleep System?

Nox Sleep System is a medical device that received FDA 510(k) clearance on 2019-11-13. The listed applicant is Nox Medical. The 510(k) number is K192469.

When did Nox Sleep System receive FDA 510(k) clearance?

Nox Sleep System received FDA 510(k) clearance on 2019-11-13, under 510(k) number K192469.

Who is the listed applicant for Nox Sleep System?

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

What is the FDA product code for Nox Sleep System?

The FDA product code for Nox Sleep System is OLZ.

Related Devices (Code: OLZ)

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.

K253390SOMNUM (SOMNUM)Honeynaps Co., Ltd.K253668Onera SleepMap (SLEEPMAP)Onera B.V.K250851Hypnos (369054-200)Cadwell Industries, Inc.K252330DeepRESPNox Medical Ehf K250058NEAT 001Brain Electrophysiology Laboratory Company, LLC K241960DeepRESPNox Medical Ehf

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.