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.
| Device ID | K203347 |
| 510k 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 |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | Suzhou Yuyue Medical Technology Co., Ltd. No. 9 Jinfeng Road, Suzhou Science & Technology Town Suzhou, CN 215163 |
| Contact | Sun Wei |
| Correspondent | Sun Wei Suzhou Yuyue Medical Technology Co., Ltd. No. 9 Jinfeng Road, Suzhou Science & Technology Town Suzhou, CN 215163 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-13 |
| Decision Date | 2021-07-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 26922166510675 | K203347 | 000 |
| 06922166510244 | K203347 | 000 |
| 26922166510804 | K203347 | 000 |
| 26922166510798 | K203347 | 000 |
| 26922166510781 | K203347 | 000 |
| 26922166510774 | K203347 | 000 |
| 26922166510767 | K203347 | 000 |
| 26922166510750 | K203347 | 000 |
| 26922166510743 | K203347 | 000 |
| 26922166510736 | K203347 | 000 |
| 26922166510729 | K203347 | 000 |
| 26922166510712 | K203347 | 000 |
| 26922166510705 | K203347 | 000 |
| 26922166510514 | K203347 | 000 |
| 26922166510521 | K203347 | 000 |
| 26922166510668 | K203347 | 000 |
| 26922166510651 | K203347 | 000 |
| 26922166510620 | K203347 | 000 |
| 26922166510613 | K203347 | 000 |
| 26922166510606 | K203347 | 000 |
| 06922166510596 | K203347 | 000 |
| 26922166510583 | K203347 | 000 |
| 26922166510576 | K203347 | 000 |
| 06922166510565 | K203347 | 000 |
| 26922166510552 | K203347 | 000 |
| 26922166510545 | K203347 | 000 |
| 26922166510538 | K203347 | 000 |
| 26922166510699 | K203347 | 000 |