The following data is part of a premarket notification filed by Shenzhen Bsx Technology Electronics Co., Ltd. with the FDA for Arm-type Electronic Blood Pressure Monitor.
| Device ID | K183058 |
| 510k Number | K183058 |
| Device Name: | Arm-type Electronic Blood Pressure Monitor |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Shenzhen BSX Technology Electronics Co., Ltd. Rm301.3F&4F, 8th Building, LiHao Industrial Area No.78 AiNan Road, Longgang Shenzhen, CN 518116 |
| Contact | Zhijian Zhao |
| Correspondent | Zhijian Zhao Shenzhen BSX Technology Electronics Co., Ltd. Rm301.3F&4F, 8th Building, LiHao Industrial Area No.78 AiNan Road, Longgang Shenzhen, CN 518116 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-02 |
| Decision Date | 2019-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06920485305831 | K183058 | 000 |
| 06920485305589 | K183058 | 000 |
| 06920485305565 | K183058 | 000 |
| 06920485305534 | K183058 | 000 |
| 06920485305381 | K183058 | 000 |
| 06920485305268 | K183058 | 000 |
| 06920485305190 | K183058 | 000 |
| 06920485305152 | K183058 | 000 |
| 06920485305138 | K183058 | 000 |
| 06920485305084 | K183058 | 000 |
| 06920485305053 | K183058 | 000 |
| 06920485305619 | K183058 | 000 |
| 06920485305633 | K183058 | 000 |
| 06920485305251 | K183058 | 000 |
| 06920485305169 | K183058 | 000 |
| 06920485305954 | K183058 | 000 |
| 06920485305930 | K183058 | 000 |
| 06920485305237 | K183058 | 000 |
| 06920485305879 | K183058 | 000 |
| 06920485305794 | K183058 | 000 |
| 06920485305787 | K183058 | 000 |
| 06920485305725 | K183058 | 000 |
| 06920485305688 | K183058 | 000 |
| 06920485305015 | K183058 | 000 |