Last synced on 24 June 2022 at 11:05 pm

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203347
510(k) Type
Traditional
Applicant
Suzhou Yuyue Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
7/2/2021
Days to Decision
231 days
Submission Type
Summary

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

Page Type
Cleared 510(K)
PDF
FDA Hosted PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K203347
510(k) Type
Traditional
Applicant
Suzhou Yuyue Medical Technology Co., Ltd.
Country
China
FDA Decision
Substantially Equivalent
Decision Date
7/2/2021
Days to Decision
231 days
Submission Type
Summary