510(k) K203347 ยท BZD Ventilator, Non-Continuous (Respirator)
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., Suzhou, CN |
| Decision | Substantially Equivalent, Jul 2, 2021 |
| Received | Nov 13, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K203347
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.