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FDA 510(k)

SLEEP QUALITY

K-Number: K070855 · 2008-03-20

ApplicantDynadx Corporation
Decision Date2008-03-20
Product CodeMNR
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SLEEP QUALITY is the device name listed in this FDA 510(k) record. The listed applicant is Dynadx Corporation. It received FDA 510(k) clearance on 2008-03-20 under 510(k) number K070855. 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 SLEEP QUALITY?

SLEEP QUALITY is a medical device that received FDA 510(k) clearance on 2008-03-20. The listed applicant is Dynadx Corporation. The 510(k) number is K070855.

When did SLEEP QUALITY receive FDA 510(k) clearance?

SLEEP QUALITY received FDA 510(k) clearance on 2008-03-20, under 510(k) number K070855.

Who is the listed applicant for SLEEP QUALITY?

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

What is the FDA product code for SLEEP QUALITY?

The FDA product code for SLEEP QUALITY 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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