The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Fully Automatic Electronic Blood Pressure Monitor.
Device ID | K163276 |
510k Number | K163276 |
Device Name: | Fully Automatic Electronic Blood Pressure Monitor |
Classification | System, Measurement, Blood-pressure, Non-invasive |
Applicant | ANDON HEALTH CO.,LTD NO 3, JIN PING ST, YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
Contact | Liu Yi |
Correspondent | Liu Yi ANDON HEALTH CO.,LTD NO 3, JIN PING ST, YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
Product Code | DXN |
CFR Regulation Number | 870.1130 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-11-21 |
Decision Date | 2017-05-11 |
Summary: | summary |