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

Ventilator, Non-continuous (respirator)

Suzhou Yuyue Medical Technology Co., Ltd.

The following data is part of a premarket notification filed by Suzhou Yuyue Medical Technology Co., Ltd. with the FDA for 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.

Pre-market Notification Details

Device IDK203347
510k NumberK203347
Device Name: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
ClassificationVentilator, Non-continuous (respirator)
Applicant Suzhou Yuyue Medical Technology Co., Ltd. No. 9 Jinfeng Road, Suzhou Science & Technology Town Suzhou,  CN 215163
ContactSun Wei
CorrespondentSun Wei
Suzhou Yuyue Medical Technology Co., Ltd. No. 9 Jinfeng Road, Suzhou Science & Technology Town Suzhou,  CN 215163
Product CodeBZD  
CFR Regulation Number868.5905 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-11-13
Decision Date2021-07-02

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