The following data is part of a premarket notification filed by Guangzhou Yongyi Industrial Co., Ltd. with the FDA for Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump.
| Device ID | K192640 |
| 510k Number | K192640 |
| Device Name: | Kidro Digital Electric Breast Pump, Dr. Brown's Digital Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Guangzhou Yongyi Industrial Co., Ltd. B3, No. 29, Qixin Road, Dongchong Town, Nansha District Guangzhou, CN 511400 |
| Contact | Jian Zhongrong |
| Correspondent | Cassie Lee Guangzhou GLOMED Biologcial Technology Co., Ltd. 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District Guangzhou, CN 510000 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-24 |
| Decision Date | 2020-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B740BF1001 | K192640 | 000 |
| 05033435136490 | K192640 | 000 |