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 |