510(k) K112573— EZSLEEP SLEEP QUALITY RECORDER

Substantially Equivalent

Platinum Team Co., Ltd.

Clearance details

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

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.