The following data is part of a premarket notification filed by Jinxinbao Electronic Co.,ltd with the FDA for Electronic Blood Pressure Monitor For Upper Arm.
Device ID | K130232 |
510k Number | K130232 |
Device Name: | ELECTRONIC BLOOD PRESSURE MONITOR FOR UPPER ARM |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | JINXINBAO ELECTRONIC CO.,LTD ROOM 404, BLDG 7, JINHUICHANG HOMELAND LIUHONGQIAO RD. Wenzhou, Zhejiang, CN 325000 |
Contact | Helen Nan |
Correspondent | Helen Nan JINXINBAO ELECTRONIC CO.,LTD ROOM 404, BLDG 7, JINHUICHANG HOMELAND LIUHONGQIAO RD. Wenzhou, Zhejiang, CN 325000 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-01-29 |
Decision Date | 2013-09-17 |
Summary: | summary |