The following data is part of a premarket notification filed by Sein Electronics Co., Ltd. with the FDA for Full Auto Fuzzy Blood Pressure Meter Model Se-7000.
| Device ID | K952826 |
| 510k Number | K952826 |
| Device Name: | FULL AUTO FUZZY BLOOD PRESSURE METER MODEL SE-7000 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | SEIN ELECTRONICS CO., LTD. ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 -2113 |
| Contact | Brenda M Kelly |
| Correspondent | Brenda M Kelly SEIN ELECTRONICS CO., LTD. ONE LETHBRIDGE PLAZA Mahwah, NJ 07430 -2113 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-20 |
| Decision Date | 1996-11-14 |