The following data is part of a premarket notification filed by Citizen Systems Japan Co., Ltd. with the FDA for Blood Pressure Meter Model Ch-101.
| Device ID | K100553 |
| 510k Number | K100553 |
| Device Name: | BLOOD PRESSURE METER MODEL CH-101 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CITIZEN SYSTEMS JAPAN CO., LTD. 3000 K STREET NW SUITE 600 Washington, DC 20007 -5143 |
| Contact | Nathan A Beaver |
| Correspondent | Nathan A Beaver CITIZEN SYSTEMS JAPAN CO., LTD. 3000 K STREET NW SUITE 600 Washington, DC 20007 -5143 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-26 |
| Decision Date | 2010-05-25 |