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Cns, Inc.

United StatesFDA applicant, unverified

Devices
14

What Cns, Inc. makes

Cns, Inc. manufactures diagnostic and monitoring devices for respiratory and neurological applications, including nasal strips for airway management, portable physiological data recorders, and electroencephalography (EEG) systems. Their portfolio includes software solutions for sleep studies, cerebral function analysis, and long-term monitoring, as well as specialized systems for recording and analyzing physiological signals. Devices like the POLY G recorder and SLEEP I/T series are designed for ambulatory sleep and neurological assessments, while the BREATHE RIGHT nasal strip addresses obstructive sleep apnea. The CEREBRAL TRACER and CNS-EP systems focus on cerebral and evoked potential monitoring with integrated software tools.

The company’s devices are classified under FDA’s Class I and Class II categories, with regulatory submissions recorded in the FDA’s 510(k) database. Products are intended for use in the United States, where compliance with FDA requirements governs their authorization. No additional international registries or classifications are specified.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue14

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  • Cerebral Tracer 1500 & Ct 1.0 Software Ref K844015

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Breathe Right Nasal Strip Ref K953772

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Respi-Pak Rt-Pak Ref K910452

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Breathe Right Nasal Strip Ref K955711

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cns-Ep System And Ep 1.0 Software Ref K860240

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cns Satellite 100, 200, 1000, 2000 Electroence. Ref K901549

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Sleep Test(Tm) Ref K950273

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Breathe Right Nasal Strip Ref K954914

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Cns-16 & Ltm 1.0 Software Ref K854160

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Poly G Physiological Data Recorder Ref K897107

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Sleep I/T-5 And Sleep I/T-8 Ref K904432

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Cns 4/8 And Ct 48.1 Software Ref K860829

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Breathe Right Ref K921220

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Am-Pak Ref K912436

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-14 of 14

Frequently asked questions

How many devices does Cns, Inc. have in the registry?

The registry currently lists 14 devices for Cns, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cns, Inc.'s devices?

Among its 14 most recently registered devices, Cns, Inc. has devices listed in FDA 510(k) (14 devices).

What risk classes do Cns, Inc.'s devices fall under?

Among its 14 most recently registered devices, the classes recorded for Cns, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Cns, Inc. in the registry?

The most recently registered devices listed for Cns, Inc. include CEREBRAL TRACER 1500 & CT 1.0 SOFTWARE, BREATHE RIGHT NASAL STRIP, RESPI-PAK RT-PAK and CNS-EP SYSTEM AND EP 1.0 SOFTWARE.

Generated automatically from registry data and not verified by a human reviewer.