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 |