The following data is part of a premarket notification filed by Nihon Seimitsu Sokki Co., Ltd. with the FDA for Ambulatory Blood Pressure Monitor, Models Fb-270 And Ds-270.
| Device ID | K093102 |
| 510k Number | K093102 |
| Device Name: | AMBULATORY BLOOD PRESSURE MONITOR, MODELS FB-270 AND DS-270 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | NIHON SEIMITSU SOKKI CO., LTD. 3F, 2-17-6 AKEBONO-CHO Tachikawa- Shi, Tokyo, JP 190-0012 |
| Contact | Koji Kubo |
| Correspondent | Koji Kubo NIHON SEIMITSU SOKKI CO., LTD. 3F, 2-17-6 AKEBONO-CHO Tachikawa- Shi, Tokyo, JP 190-0012 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-01 |
| Decision Date | 2010-06-03 |
| Summary: | summary |