The following data is part of a premarket notification filed by Ya Horng Electronic Co., Ltd. with the FDA for Amluck, Ya Horng.
| Device ID | K042581 |
| 510k Number | K042581 |
| Device Name: | AMLUCK, YA HORNG |
| 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 Ke-min |
| Correspondent | Jen Ke-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 | 2004-09-22 |
| Decision Date | 2004-10-13 |
| Summary: | summary |