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FDA 510(k)

MDRIVE

K-Number: K111742 · 2011-08-31

ApplicantEmbla Systems
Decision Date2011-08-31
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MDRIVE is the device name listed in this FDA 510(k) record. The listed applicant is Embla Systems. It received FDA 510(k) clearance on 2011-08-31 under 510(k) number K111742. 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 MDRIVE?

MDRIVE is a medical device that received FDA 510(k) clearance on 2011-08-31. The listed applicant is Embla Systems. The 510(k) number is K111742.

When did MDRIVE receive FDA 510(k) clearance?

MDRIVE received FDA 510(k) clearance on 2011-08-31, under 510(k) number K111742.

Who is the listed applicant for MDRIVE?

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

What is the FDA product code for MDRIVE?

The FDA product code for MDRIVE is MNR.

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Other records listing Embla Systems as applicant

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Related Devices (Code: MNR)

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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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