The following data is part of a premarket notification filed by Ya Horng Electronic Co., Ltd. with the FDA for Ya Horng Blood Pressure Monitor, Ya Horng Blood Pressure Monitor, Bluetooth Transmission.
| Device ID | K121025 |
| 510k Number | K121025 |
| Device Name: | YA HORNG BLOOD PRESSURE MONITOR, YA HORNG BLOOD PRESSURE MONITOR, BLUETOOTH TRANSMISSION |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | YA HORNG ELECTRONIC CO., LTD. NO. 58, FU-CHIUN ST. Hsin-chu City, TW 30067 |
| Contact | Jen Ke-min |
| Correspondent | Jen Ke-min 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 | 2012-04-04 |
| Decision Date | 2012-08-17 |
| Summary: | summary |