The following data is part of a premarket notification filed by Shenzhen Jamr Technology Co.,ltd with the FDA for Upper Arm Type Blood Pressure Monitor.
Device ID | K220886 |
510k Number | K220886 |
Device Name: | Upper Arm Type Blood Pressure Monitor |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | Shenzhen Jamr Technology Co.,Ltd A101-301,D101-201, Jamr Science & Technology Park, No. 2 Guiyuan Road, Guixiang Community Shenzhen, CN 518100 |
Contact | Luo Fusheng |
Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 1407, Jingting Building, Dongzhou Community, Guangming Street, Guangming District Shenzhen, CN 518000 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-28 |
Decision Date | 2022-07-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00863398000225 | K220886 | 000 |
10810113577569 | K220886 | 000 |
06927709401966 | K220886 | 000 |
06927709400976 | K220886 | 000 |