The following data is part of a premarket notification filed by Honsun (nantong) Co., Ltd. with the FDA for Automatic Digital Blood Pressure Monitor.
| Device ID | K132627 |
| 510k Number | K132627 |
| Device Name: | AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HONSUN (NANTONG) CO., LTD. NO.8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, Jiangsu, CN 226009 |
| Contact | Selina Qian |
| Correspondent | Selina Qian HONSUN (NANTONG) CO., LTD. NO.8, Tongxing Road, Nantong Economic & Technological Development Area Nantong, Jiangsu, CN 226009 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-22 |
| Decision Date | 2013-10-23 |