Nox Sleep System
K-Number: K192469 · 2019-11-13
ApplicantNox Medical
Decision Date2019-11-13
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Nox Sleep System is a medical device manufactured by Nox Medical. It received FDA 510(k) clearance on 2019-11-13 under approval 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. It is manufactured by Nox Medical. The 510(k) number is K192469.
When was Nox Sleep System approved by the FDA?
Nox Sleep System received FDA 510(k) clearance on 2019-11-13, under approval number K192469.
What company makes Nox Sleep System?
Nox Sleep System is manufactured by Nox Medical.
What is the FDA product code for Nox Sleep System?
The FDA product code for Nox Sleep System is OLZ.
Related Clinical Trials
NCT05016219
Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients
RECRUITING
NCT07608614
Sleep and Performance
RECRUITING
NCT04121923
Validation of a Novel Device for Screening Patients With Symptoms of Obstructive Sleep Apnea
COMPLETED
NCT02703207
Neurocognitive and Health Impact of Sleep Apnea in Elderly Veterans With Comorbid COPD
RECRUITING
NCT00743561
Assessment of Ambulatory Polygraphy in the Detection of Sleep Apnea in Multiple System Atrophy (SAMSA)
COMPLETED
NCT07574918
Measuring Nasal Airway Changes After VivAer Treatment Using AI Analysis
NOT_YET_RECRUITING
Related Devices (Code: OLZ)
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.