The following data is part of a premarket notification filed by Joytech Healthcare Co.,ltd with the FDA for Non-invasive Blood Pressure Measurement Systems.
Device ID | K173024 |
510k Number | K173024 |
Device Name: | Non-invasive Blood Pressure Measurement Systems |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | Joytech Healthcare Co.,Ltd No. 365 Wuzhou Road, Yuhang Economic Development Zone Hangzhou, CN 311100 |
Contact | Ren Yunhua |
Correspondent | Ren Yunhua Joytech Healthcare Co.,Ltd No. 365 Wuzhou Road, Yuhang Economic Development Zone Hangzhou, CN 311100 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-28 |
Decision Date | 2018-08-22 |
Summary: | summary |