Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

POLYSMITH SLEEP SYSTEM, MODEL NTI5498

K-Number: K062943 · 2007-05-09

ApplicantNeurotronics, Inc.
Decision Date2007-05-09
Product CodeOLZ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POLYSMITH SLEEP SYSTEM, MODEL NTI5498 is the device name listed in this FDA 510(k) record. The listed applicant is Neurotronics, Inc.. It received FDA 510(k) clearance on 2007-05-09 under 510(k) number K062943. 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 POLYSMITH SLEEP SYSTEM, MODEL NTI5498?

POLYSMITH SLEEP SYSTEM, MODEL NTI5498 is a medical device that received FDA 510(k) clearance on 2007-05-09. The listed applicant is Neurotronics, Inc.. The 510(k) number is K062943.

When did POLYSMITH SLEEP SYSTEM, MODEL NTI5498 receive FDA 510(k) clearance?

POLYSMITH SLEEP SYSTEM, MODEL NTI5498 received FDA 510(k) clearance on 2007-05-09, under 510(k) number K062943.

Who is the listed applicant for POLYSMITH SLEEP SYSTEM, MODEL NTI5498?

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

What is the FDA product code for POLYSMITH SLEEP SYSTEM, MODEL NTI5498?

The FDA product code for POLYSMITH SLEEP SYSTEM, MODEL NTI5498 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_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Neurotronics, Inc. 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.

K220631NomadAir PMU810K181709Serenity Piezo Sensor, Serenity Thermocouple SensorK173868Serenity Body Position Sensor, Serenity RIP SensorsK161650Polysmith Sleep System, Model NTI7593K131415LIVE VIEW PANEL (LVP)K092699NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800

View all 8 devices →

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.

↑