The following data is part of a premarket notification filed by Ningbo Huiyoo Baby Products Co. Ltd. with the FDA for Electric Breast Pump.
| Device ID | K191802 |
| 510k Number | K191802 |
| Device Name: | Electric Breast Pump |
| Classification | Pump, Breast, Powered |
| Applicant | Ningbo Huiyoo Baby Products Co. Ltd. 523# Cizhang Road, Zhangqi Industrial Area Cixi, CN 315313 |
| Contact | Xiaoping Liu |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O Box 120-119 Shanghai, CN 200120 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-03 |
| Decision Date | 2020-01-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06972562618235 | K191802 | 000 |
| 06972562618068 | K191802 | 000 |
| 06972562618051 | K191802 | 000 |
| 06972562618044 | K191802 | 000 |
| 06972562618037 | K191802 | 000 |
| 06972562618020 | K191802 | 000 |
| 06972562618013 | K191802 | 000 |
| 06972562618327 | K191802 | 000 |
| 06972562618310 | K191802 | 000 |
| 06972562618303 | K191802 | 000 |
| 06972562618297 | K191802 | 000 |
| 06972562618358 | K191802 | 000 |
| 06972562618341 | K191802 | 000 |
| 06972562618099 | K191802 | 000 |
| 06972562618105 | K191802 | 000 |
| 06972562618228 | K191802 | 000 |
| 06972562618211 | K191802 | 000 |
| 06972562618204 | K191802 | 000 |
| 06972562618198 | K191802 | 000 |
| 06972562618181 | K191802 | 000 |
| 06972562618174 | K191802 | 000 |
| 06972562618167 | K191802 | 000 |
| 06972562618150 | K191802 | 000 |
| 06972562618143 | K191802 | 000 |
| 06972562618136 | K191802 | 000 |
| 06972562618129 | K191802 | 000 |
| 06972562618112 | K191802 | 000 |
| 06972562618334 | K191802 | 000 |