The following data is part of a premarket notification filed by Citizen Watch Co., Ltd. with the FDA for Blood Pressure Meter, Models Ch-631b, Ch-631d, Ch-632b, Ch-632d.
| Device ID | K001244 |
| 510k Number | K001244 |
| Device Name: | BLOOD PRESSURE METER, MODELS CH-631B, CH-631D, CH-632B, CH-632D |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CITIZEN WATCH CO., LTD. 3000 K STREET, N.W., SUITE 500 Washington, DC 20007 |
| Contact | Joseph D Edmondson |
| Correspondent | Joseph D Edmondson CITIZEN WATCH CO., LTD. 3000 K STREET, N.W., SUITE 500 Washington, DC 20007 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-18 |
| Decision Date | 2000-09-26 |