The following data is part of a premarket notification filed by Wenzhou Bokang Instruments Co., Ltd. with the FDA for Bokang Semi-auto / Automatic / Wrist Digital Blood Pressure Monitor.
| Device ID | K111141 |
| 510k Number | K111141 |
| Device Name: | BOKANG SEMI-AUTO / AUTOMATIC / WRIST DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | WENZHOU BOKANG INSTRUMENTS CO., LTD. HAINING ROAD, HAIBIN LONGWAN Wenzhou, Zhejiang P.r., CN 325024 |
| Contact | Johnny Cao |
| Correspondent | Johnny Cao WENZHOU BOKANG INSTRUMENTS CO., LTD. HAINING ROAD, HAIBIN LONGWAN Wenzhou, Zhejiang P.r., CN 325024 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-22 |
| Decision Date | 2012-02-21 |
| Summary: | summary |