The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Electronic Digital Blood Pressure Monitor.
| Device ID | K882635 |
| 510k Number | K882635 |
| Device Name: | ELECTRONIC DIGITAL BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 1125-7 SEKISHITA Shibukawa-shi, Gunma-ken, JP 377-0293 |
| Contact | Itsuo Nagai |
| Correspondent | Itsuo Nagai NIHON SEIMITSU SOKKI CO., LTD. 1125-7 SEKISHITA Shibukawa-shi, Gunma-ken, JP 377-0293 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-27 |
| Decision Date | 1988-11-09 |