The following data is part of a premarket notification filed by Shenzhen Jamr Medical Technology Co., Limited with the FDA for Digital Blood Pressure Monitor Models: B01, B02, B05 & B06t.
Device ID | K172171 |
510k Number | K172171 |
Device Name: | Digital Blood Pressure Monitor Models: B01, B02, B05 & B06T |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | Shenzhen Jamr Medical Technology CO., Limited 2nd Floor, A-building, No.2 Guiyuan Road, Guihua Community, Guanlan Town, L Shenzhen, CN 518110 |
Contact | Li Xue |
Correspondent | Mei Tan Chonconn Medical Device Consulting Co.LTD. 22A, HaiJing Square, No.18 Taizi Road, Nanshan District Shenzhen, CN 518067 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-07-18 |
Decision Date | 2017-12-21 |
Summary: | summary |