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FDA 510(k)

SILENT NIGHT V

K-Number: K000253 · 2000-11-16

ApplicantSleep Solutions, Inc.
Decision Date2000-11-16
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SILENT NIGHT V is the device name listed in this FDA 510(k) record. The listed applicant is Sleep Solutions, Inc.. It received FDA 510(k) clearance on 2000-11-16 under 510(k) number K000253. 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 SILENT NIGHT V?

SILENT NIGHT V is a medical device that received FDA 510(k) clearance on 2000-11-16. The listed applicant is Sleep Solutions, Inc.. The 510(k) number is K000253.

When did SILENT NIGHT V receive FDA 510(k) clearance?

SILENT NIGHT V received FDA 510(k) clearance on 2000-11-16, under 510(k) number K000253.

Who is the listed applicant for SILENT NIGHT V?

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

What is the FDA product code for SILENT NIGHT V?

The FDA product code for SILENT NIGHT V 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.

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 Sleep Solutions, 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.

K981034SILENT NIGHT II

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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