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FDA 510(k)

NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM

K-Number: K070326 · 2007-05-05

ApplicantWidemed, Ltd.
Decision Date2007-05-05
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

NOGA AUTOMATED SLEEP STUDY SCORING AND 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 2007-05-05 under 510(k) number K070326. 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 NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM?

NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM is a medical device that received FDA 510(k) clearance on 2007-05-05. The listed applicant is Widemed, Ltd.. The 510(k) number is K070326.

When did NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM receive FDA 510(k) clearance?

NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM received FDA 510(k) clearance on 2007-05-05, under 510(k) number K070326.

Who is the listed applicant for NOGA AUTOMATED SLEEP STUDY SCORING AND 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 NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM?

The FDA product code for NOGA AUTOMATED SLEEP STUDY SCORING AND DATA MANAGEMENT SYSTEM 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 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 OXK022506MORPHEUS 1, AUTOMATED SLEEP STUDY SCORING & 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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