The following data is part of a premarket notification filed by Honsun (nantong) Co., Ltd with the FDA for Wrist Automatic Blood Pressure Monitor.
| Device ID | K131463 |
| 510k Number | K131463 |
| Device Name: | WRIST AUTOMATIC BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HONSUN (NANTONG) CO., LTD NO.8, TONGXING ROAD Jiangsu, CN 226009 |
| Contact | Selina Qian |
| Correspondent | Selina Qian HONSUN (NANTONG) CO., LTD NO.8, TONGXING ROAD Jiangsu, CN 226009 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-21 |
| Decision Date | 2013-07-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00370393904019 | K131463 | 000 |
| 00697038425648 | K131463 | 000 |
| 00697038425624 | K131463 | 000 |
| 10697038425621 | K131463 | 000 |
| 01697038425005 | K131463 | 000 |
| 06970384250640 | K131463 | 000 |