The following data is part of a premarket notification filed by Qingdao Future Medical Technology Co., Ltd. with the FDA for Intelligent Mesh Nebulizer.
| Device ID | K171549 |
| 510k Number | K171549 |
| Device Name: | Intelligent Mesh Nebulizer |
| Classification | Nebulizer (direct Patient Interface) |
| Applicant | Qingdao Future Medical Technology Co., Ltd. Room 401 Building F, No. 169 Zhuzhou Road, Laoshan District Qingdao, CN 266001 |
| Contact | Wang Weilai |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-402, Bldg #27, YangGuangYiShang, No.56, LiangXiang East Rd., FangShan Beijing, CN 102401 |
| Product Code | CAF |
| CFR Regulation Number | 868.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-05-26 |
| Decision Date | 2018-08-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 16971331400191 | K171549 | 000 |
| 16971331400184 | K171549 | 000 |
| 16971331400160 | K171549 | 000 |
| 16971331400207 | K171549 | 000 |
| 06971331400033 | K171549 | 000 |
| 06971331400019 | K171549 | 000 |
| 00860003079706 | K171549 | 000 |