The following data is part of a premarket notification filed by Honsun(nantong)co.,ltd with the FDA for Scian Automatic Digital Blood Pressure Monitor, Model: Ld-576, Ld-575 & Ld-579.
| Device ID | K170866 |
| 510k Number | K170866 |
| Device Name: | Scian Automatic Digital Blood Pressure Monitor, Model: LD-576, LD-575 & LD-579 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | Honsun(Nantong)Co.,Ltd No.8,Tongxing Road, Economic&Technology Development Zone Nantong Nantong, CN 226009 |
| Contact | Selina Qian |
| Correspondent | Selina Qian Honsun(Nantong)Co.,Ltd No.8,Tongxing Road, Economic&Technology Development Zone Nantong Nantong, 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 | 2017-03-23 |
| Decision Date | 2018-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970384250954 | K170866 | 000 |
| 06970384250657 | K170866 | 000 |
| 06970384250961 | K170866 | 000 |