The following data is part of a premarket notification filed by Ya Horng Electronic Co., Ltd. with the FDA for Ya Horng Digital Upper Arm Blood Pressure Monitor, Bp-100j, Bp-110j; Digital Wrist Blood Pressure Monitor, Bp-500,bp-500.
| Device ID | K072860 |
| 510k Number | K072860 |
| Device Name: | YA HORNG DIGITAL UPPER ARM BLOOD PRESSURE MONITOR, BP-100J, BP-110J; DIGITAL WRIST BLOOD PRESSURE MONITOR, BP-500,BP-500 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | YA HORNG ELECTRONIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Ke-min Jen |
| Correspondent | Ke-min Jen YA HORNG ELECTRONIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-05 |
| Decision Date | 2008-02-25 |
| Summary: | summary |