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FDA 510(k)

EZSLEEP SLEEP QUALITY RECORDER

K-Number: K112573 · 2012-03-22

ApplicantPlatinum Team Co., Ltd.
Decision Date2012-03-22
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EZSLEEP SLEEP QUALITY RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Platinum Team Co., Ltd.. It received FDA 510(k) clearance on 2012-03-22 under 510(k) number K112573. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EZSLEEP SLEEP QUALITY RECORDER?

EZSLEEP SLEEP QUALITY RECORDER is a medical device that received FDA 510(k) clearance on 2012-03-22. The listed applicant is Platinum Team Co., Ltd.. The 510(k) number is K112573.

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

EZSLEEP SLEEP QUALITY RECORDER received FDA 510(k) clearance on 2012-03-22, under 510(k) number K112573.

Who is the listed applicant for EZSLEEP SLEEP QUALITY RECORDER?

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

What is the FDA product code for EZSLEEP SLEEP QUALITY RECORDER?

The FDA product code for EZSLEEP SLEEP QUALITY RECORDER is MWJ.

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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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