The following data is part of a premarket notification filed by Ya Horng Electronic Co., Ltd. with the FDA for Amluck Ya Horng Pc Compatible Wrist Blood Pressure Monitor, Model Ak-4000t.
Device ID | K040528 |
510k Number | K040528 |
Device Name: | AMLUCK YA HORNG PC COMPATIBLE WRIST BLOOD PRESSURE MONITOR, MODEL AK-4000T |
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 | 2004-03-01 |
Decision Date | 2004-04-15 |
Summary: | summary |