The following data is part of a premarket notification filed by Wuxi Xinzhongrui Baby Supplies Co., Ltd. with the FDA for Megna Breast Pumps.
| Device ID | K142479 |
| 510k Number | K142479 |
| Device Name: | MEGNA BREAST PUMPS |
| Classification | Pump, Breast, Powered |
| Applicant | WUXI XINZHONGRUI BABY SUPPLIES CO., LTD. NO.117 XINHUA ROAD, MEICUN, NEW DISTRICT Wuxi City, CN 214000 |
| Contact | Anne Chen |
| Correspondent | David Zeng MEGNA INC. 1043 ANDREW DRIVE West Chester, PA 19380 |
| Product Code | HGX |
| CFR Regulation Number | 884.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-04 |
| Decision Date | 2015-02-24 |