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FDA 510(k)

SLEEPSTRIP II

K-Number: K112822 · 2011-12-27

ApplicantS.L.P. , Ltd.
Decision Date2011-12-27
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEPSTRIP II is the device name listed in this FDA 510(k) record. The listed applicant is S.L.P. , Ltd.. It received FDA 510(k) clearance on 2011-12-27 under 510(k) number K112822. 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 SLEEPSTRIP II?

SLEEPSTRIP II is a medical device that received FDA 510(k) clearance on 2011-12-27. The listed applicant is S.L.P. , Ltd.. The 510(k) number is K112822.

When did SLEEPSTRIP II receive FDA 510(k) clearance?

SLEEPSTRIP II received FDA 510(k) clearance on 2011-12-27, under 510(k) number K112822.

Who is the listed applicant for SLEEPSTRIP II?

The FDA 510(k) record lists S.L.P. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLEEPSTRIP II?

The FDA product code for SLEEPSTRIP II is MNR.

Related Clinical Trials

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Other records listing S.L.P. , Ltd. 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.

K191574OxSAT 100K080375RMX PHYSIOLOGICAL DATA RECORDERK042253SLEEPSENSE SLEEP SENSORSK030869BITESTRIP

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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