The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Ambulatory Blood Pressure Monitoring System, Model Se-25m/25p.
| Device ID | K003711 |
| 510k Number | K003711 |
| Device Name: | AMBULATORY BLOOD PRESSURE MONITORING SYSTEM, MODEL SE-25M/25P |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEIN ELECTRONICS CO., LTD. 133-3, PYUNGCHON-DONG Anyang-city, Kyunggi-do, KR |
| Contact | Won-ky Kim |
| Correspondent | Charles Mack UNDERWRITERS LABORATORIES, INC. 333 PFINGSTEN RD. Northbrook, IL 60062 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-12-01 |
| Decision Date | 2000-12-15 |