The following data is part of a premarket notification filed by Visiomed Technology Co.,ltd with the FDA for Handheld Vitalsigns Monitoring System.
| Device ID | K172965 |
| 510k Number | K172965 |
| Device Name: | Handheld VitalSigns Monitoring System |
| Classification | Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Applicant | Visiomed Technology Co.,Ltd 2 Floor Of No.1 Building, Jia An Technological Industial Park, 67 District, Bao An, Shenzhen,, CN 518000 |
| Contact | Chen Xiaofeng |
| Correspondent | Filed Fu Shenzhen Joyantech Consulting Co., Ltd 1122#, International Mayor Communication Center, Baishizhong Road 55# Nanshan District, Shenzhen, CN 518000 |
| Product Code | MWI |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-26 |
| Decision Date | 2018-12-17 |
| Summary: | summary |