The following data is part of a premarket notification filed by Ya Horng Electronic Co., Ltd. with the FDA for Tricot Blood Pressure Cuff.
Device ID | K051539 |
510k Number | K051539 |
Device Name: | TRICOT BLOOD PRESSURE CUFF |
Classification | Blood Pressure Cuff |
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 | DXQ |
CFR Regulation Number | 870.1120 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-06-10 |
Decision Date | 2005-08-05 |
Summary: | summary |