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 by Suzhou Yuyue Medical Technology Co., Ltd. — Product Code BZD

K203347 is an FDA 510(k) premarket notification submitted by Suzhou Yuyue Medical Technology Co., Ltd. for the device "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". The FDA issued a decision of Substantially Equivalent on Jul 2, 2021. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905.