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FDA 510(k)

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM

K-Number: K022506 · 2003-05-15

ApplicantWidemed, Ltd.
Decision Date2003-05-15
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Widemed, Ltd.. It received FDA 510(k) clearance on 2003-05-15 under 510(k) number K022506. 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 MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM?

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2003-05-15. The listed applicant is Widemed, Ltd.. The 510(k) number is K022506.

When did MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 2003-05-15, under 510(k) number K022506.

Who is the listed applicant for MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM?

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

What is the FDA product code for MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM?

The FDA product code for MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & DATA MANAGEMENT SYSTEM is MNR.

Related Clinical Trials

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Other records listing Widemed, 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.

K111314MORPHEUS OXK070326NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM

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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