Name: Predicase
Price: 199 USD

K-number	K203347
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
Applicant	Suzhou Yuyue Medical Technology Co., Ltd.
Product code	BZD
Device class	Class II
Decision date	Jul 2, 2021
Decision	Substantially Equivalent
Regulation	868.5905

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View the full FDA submission: accessdata.fda.gov

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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

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