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FDA 510(k)

SLEEP TEST(TM)

K-Number: K950273 · 1995-09-19

ApplicantCns, Inc.
Decision Date1995-09-19
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEP TEST(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Cns, Inc.. It received FDA 510(k) clearance on 1995-09-19 under 510(k) number K950273. The device is classified under product code MNR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLEEP TEST(TM)?

SLEEP TEST(TM) is a medical device that received FDA 510(k) clearance on 1995-09-19. The listed applicant is Cns, Inc.. The 510(k) number is K950273.

When did SLEEP TEST(TM) receive FDA 510(k) clearance?

SLEEP TEST(TM) received FDA 510(k) clearance on 1995-09-19, under 510(k) number K950273.

Who is the listed applicant for SLEEP TEST(TM)?

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

What is the FDA product code for SLEEP TEST(TM)?

The FDA product code for SLEEP TEST(TM) is MNR.

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.

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Other records listing Cns, 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.

K955711BREATHE RIGHT NASAL STRIPK954914BREATHE RIGHT NASAL STRIPK953772BREATHE RIGHT NASAL STRIPK921220BREATHE RIGHTK912436AM-PAKK904432SLEEP I/T-5 AND SLEEP I/T-8

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Related Devices (Code: MNR)

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.

K260949Disposable Belts for Polysomnography (CNSAC)CNSAC Medshop GmbHK254042WatchPAT SWItamar Medical , Ltd.K260050WRAP SystemHuneo, LLCK253148RX-1 SleepVivaquant, Inc. Dba Rhythm ExpressK252628CASSIEWesper, Inc.K252497SANSA HSATHuxley Medical

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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