The following data is part of a premarket notification filed by Beijing Fert Technology Co., Ltd with the FDA for Burette-type Infusion Sets For Single Use, Disposable Infusion Sets With Precision Filters, Disposable Infusion Set.
| Device ID | K161898 |
| 510k Number | K161898 |
| Device Name: | Burette-type Infusion Sets For Single Use, Disposable Infusion Sets With Precision Filters, Disposable Infusion Set |
| Classification | Set, Administration, Intravascular |
| Applicant | BEIJING FERT TECHNOLOGY CO., LTD NO.9, ZHANGGUOZHUANG VILLAGE, CHANGXINDIAN TOWN FENG TAI DISTRICT Beijing, CN 100072 |
| Contact | Meng Zhang |
| Correspondent | Diana Hong MID-LINK CONSULTING CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2017-03-08 |
| Summary: | summary |