The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Full Auto Blood Pressure Monitor, Model Se-7700h.
| Device ID | K003282 |
| 510k Number | K003282 |
| Device Name: | FULL AUTO BLOOD PRESSURE MONITOR, MODEL SE-7700H |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEIN ELECTRONICS CO., LTD. 196 ANYANG 7 DONG, MANAN-KU YOUCHEON FACTOPIA RM. #506 Anyang-city, Kyungki-do, KR 206 |
| Contact | Won Ky Kim |
| Correspondent | Robert Boonstra 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 | 2000-10-19 |
| Decision Date | 2000-11-01 |