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FDA 510(k)

MICHELE SLEEP SCORING SYSTEMS

K-Number: K112102 · 2011-12-20

ApplicantYounes Sleep Technologies
Decision Date2011-12-20
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MICHELE SLEEP SCORING SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Younes Sleep Technologies. It received FDA 510(k) clearance on 2011-12-20 under 510(k) number K112102. 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 MICHELE SLEEP SCORING SYSTEMS?

MICHELE SLEEP SCORING SYSTEMS is a medical device that received FDA 510(k) clearance on 2011-12-20. The listed applicant is Younes Sleep Technologies. The 510(k) number is K112102.

When did MICHELE SLEEP SCORING SYSTEMS receive FDA 510(k) clearance?

MICHELE SLEEP SCORING SYSTEMS received FDA 510(k) clearance on 2011-12-20, under 510(k) number K112102.

Who is the listed applicant for MICHELE SLEEP SCORING SYSTEMS?

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

What is the FDA product code for MICHELE SLEEP SCORING SYSTEMS?

The FDA product code for MICHELE SLEEP SCORING SYSTEMS is MNR.

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Related Devices (Code: MNR)

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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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