EZSLEEP SLEEP QUALITY RECORDER— 510(k) K112573

Name: FDA 510(k) clearance K112573
Creator: U.S. Food and Drug Administration
Published: 2012-03-22

Substantially Equivalent

Platinum Team Co., Ltd.

FDA 510(k) clearance K112573 for EZSLEEP SLEEP QUALITY RECORDER, Substantially Equivalent on 2012-03-22. Applicant: Platinum Team Co., Ltd.. Device class: 2.

Clearance details

Applicant: Platinum Team Co., Ltd.
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2011-09-06
Decision date: 2012-03-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipai, TW

Download summary PDF View on FDA.gov ↗

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Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.