The following data is part of a premarket notification filed by Shantou Xinghe Electrical Apparatuses Co., Ltd with the FDA for Electric Breast Pump.
Device ID | K143585 |
510k Number | K143585 |
Device Name: | Electric Breast Pump |
Classification | Pump, Breast, Powered |
Applicant | SHANTOU XINGHE ELECTRICAL APPARATUSES CO., LTD NO.8, YI ROAD, PINGBEI INDUSTRIAL ZONE CHAOYANG DISTRICT Shantou, Guangdong, CN 515100 |
Contact | Jun Deng |
Correspondent | Mike Gu Guangzhou Osmunda Medical Device Technical Services., Ltd. 7th Floor, Jingui Business Building, No. 982 Congyun Rd., Baiyun District, CN 510420 |
Product Code | HGX |
CFR Regulation Number | 884.5160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2014-12-18 |
Decision Date | 2015-05-06 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06975740360711 | K143585 | 000 |
06975740369721 | K143585 | 000 |
00810115233763 | K143585 | 000 |
00810115233718 | K143585 | 000 |
06940657902033 | K143585 | 000 |
06940657902019 | K143585 | 000 |
00694065790206 | K143585 | 000 |