The following data is part of a premarket notification filed by Honsun(nantong) Co., Ltd. with the FDA for Automatic Blood Pressure Monitor Model Ld-518 & Ld-537.
| Device ID | K170466 |
| 510k Number | K170466 |
| Device Name: | Automatic Blood Pressure Monitor Model LD-518 & LD-537 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Honsun(Nantong) Co., Ltd. No.8,Tongxing Road, Nantong Economic & Technology Development Zone Nantong, CN 226009 |
| Contact | Selina Qian |
| Correspondent | Selina Qian Honsun(Nantong) Co., Ltd. No.8,Tongxing Road, Nantong Economic & Technology Development Zone Nantong, 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 | 2017-02-15 |
| Decision Date | 2017-10-27 |