The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Ambulatory Blood Pressure Monitor, Models: Sa-10, Sa-05, Sa-06, Sa-08 And Sa-09.
|Device Name:||Ambulatory Blood Pressure Monitor, Models: SA-10, SA-05, SA-06, SA-08 And SA-09|
|Classification||System, Measurement, Blood-pressure, Non-invasive|
|Applicant||Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, CN 518122|
Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District, Pingshan District Shenzhen, CN 518122
|CFR Regulation Number||870.1130 [🔎]|
|Decision||Substantially Equivalent (SESE)|
|3rd Party Reviewed||No|