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FDA 510(k)

Sleep Analysis Module

K-Number: K261521 · 2026-10-09

ApplicantNeurotronics, LLC
Decision Date2026-10-09
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

Sleep Analysis Module is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, LLC. It received FDA 510(k) clearance on 2026-10-09 under 510(k) number K261521. 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 Sleep Analysis Module?

Sleep Analysis Module is a medical device that received FDA 510(k) clearance on 2026-10-09. The listed applicant is Neurotronics, LLC. The 510(k) number is K261521.

When did Sleep Analysis Module receive FDA 510(k) clearance?

Sleep Analysis Module received FDA 510(k) clearance on 2026-10-09, under 510(k) number K261521.

Who is the listed applicant for Sleep Analysis Module?

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

What is the FDA product code for Sleep Analysis Module?

The FDA product code for Sleep Analysis Module is OLZ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT04745156A Study Using Brain Stimulation and Behavioral Therapy to Increase Extent of Resection in Low-Grade GliomasNOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED

Other records listing Neurotronics, LLC as applicant

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.

K251480PV01 PVDF Effort Sensor

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 EhfK250058NEAT 001Brain Electrophysiology Laboratory Company, LLCK241960DeepRESPNox Medical Ehf

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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