The following data is part of a premarket notification filed by Shenzhen Jiacom Technology Co ., Ltd with the FDA for Arm Type Automatic Blood Pressure Monitor Bp310a, Bp313a, Bp351a, Bp362a, Bp366a, Bp369a, Bp380a, Bp389a, Bp-jc312.
| Device ID | K172896 |
| 510k Number | K172896 |
| Device Name: | Arm Type Automatic Blood Pressure Monitor BP310A, BP313A, BP351A, BP362A, BP366A, BP369A, BP380A, BP389A, BP-JC312 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen Jiacom Technology Co ., Ltd No. A6 Building, Silicon Valley Power Qinghu Park, Longhua Street, Bao’an Dist Shenzhen, CN 518109 |
| Contact | Luo Tianfeng |
| Correspondent | Diana Hong Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, CN 200120 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-22 |
| Decision Date | 2018-01-26 |
| Summary: | summary |