The following data is part of a premarket notification filed by Vales & Hills Biomedical Tech. Ltd. with the FDA for Ecg Acquisition Systems.
| Device ID | K163607 |
| 510k Number | K163607 |
| Device Name: | ECG Acquisition Systems |
| Classification | Electrocardiograph |
| Applicant | VALES & HILLS BIOMEDICAL TECH. LTD. No.2 North Street Jingyuan Beijing Economic-technological Development Aera Beijing, CN 100176 |
| Contact | Jianfang Liu |
| Correspondent | Field Fu Shenzhen Joyantech Consulting Co., Ltd. NO. 55 Shizhou Middle Road, Nanshan District Shenzhen, CN 518000 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-21 |
| Decision Date | 2017-12-15 |