The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Full Auto Wrist Digital Blood Pressure Monitor Model# Se-311.
| Device ID | K042138 |
| 510k Number | K042138 |
| Device Name: | FULL AUTO WRIST DIGITAL BLOOD PRESSURE MONITOR MODEL# SE-311 |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-08-09 |
| Decision Date | 2004-08-24 |
| Summary: | summary |