The following data is part of a premarket notification filed by Ya Horng Electronic Co., Ltd. with the FDA for Pc Compatible Blood Pressure Monitor, Model Ak-4000tu, Bp-410u, Bp-410r; Automatic Digital Wrist Blood Press. Monitor..
| Device ID | K051862 |
| 510k Number | K051862 |
| Device Name: | PC COMPATIBLE BLOOD PRESSURE MONITOR, MODEL AK-4000TU, BP-410U, BP-410R; AUTOMATIC DIGITAL WRIST BLOOD PRESS. MONITOR. |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | YA HORNG ELECTRONIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Contact | Jen Ken-min |
| Correspondent | Jen Ken-min YA HORNG ELECTRONIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 300 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-08 |
| Decision Date | 2005-08-23 |
| Summary: | summary |