| Device Classification Name |
Analyzer, Body Composition
|
| 510(k) Number |
K231116 |
| Device Name |
Multi-parameter detector |
| Applicant |
| Zhongshan Jinli Electronic Weighing Equipment Co., Ltd. |
| 283rd S. Min'An Rd., Xiaolan Town, Zhongshan City, |
| Guangdong, China |
|
Zhongshan,
CN
528400
|
|
| Applicant Contact |
Jerry Liang |
| Correspondent |
| Shenzhen Joyantech Consulting Co., Ltd. |
| 1713a, 17th Floor, Block A, Zhongguan Times Square |
| Liuxian Ave., Xili Town, Nanshan District, |
|
Shenzhen,
CN
518000
|
|
| Correspondent Contact |
Liz Li |
| Regulation Number | 870.2770 |
| Classification Product Code |
|
| Subsequent Product Codes |
|
| Date Received | 04/20/2023 |
| Decision Date | 06/15/2024 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Cardiovascular
|
| 510k Review Panel |
Cardiovascular
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|