510(k) K203347— Sleep Apnea Breathing Therapy Mask: YF-01 Full Face Mask, YF-02 Full Face Mask, YF-03 Full Face Mask, YN-02 Nasal Mask, YN-03 Nasal Mask, YP-01 Nasal Pillow Mask

Substantially Equivalent

Suzhou Yuyue Medical Technology Co., Ltd.

Clearance details

Applicant: Suzhou Yuyue Medical Technology Co., Ltd.
Product code: Code BZD
Advisory panel: Anesthesiology
Date received: 2020-11-13
Decision date: 2021-07-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Suzhou, CN

Adverse events under product code BZD

product code BZD

Death: 4,440
Injury: 53,099
Malfunction: 213,222
Other: 17
Total: 270,778

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.