The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Full Auto Arm Digital Blood Pressure Monitor.
| Device ID | K032927 |
| 510k Number | K032927 |
| Device Name: | FULL AUTO ARM DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEIN ELECTRONICS CO., LTD. 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour SEIN ELECTRONICS CO., LTD. 1308 MORNINGSIDE PARK DRIVE Alpharetta, GA 30022 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-22 |
| Decision Date | 2004-05-07 |
| Summary: | summary |