The following data is part of a premarket notification filed by Citizen Watch Co., Ltd. with the FDA for Blood Pressure Meter, Models Ch-491, Ch-481, Ch-471.
| Device ID | K984223 |
| 510k Number | K984223 |
| Device Name: | BLOOD PRESSURE METER, MODELS CH-491, CH-481, CH-471 |
| 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 Jr |
| Correspondent | Joseph D Edmondson Jr 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-25 |
| Decision Date | 1999-04-28 |
| Summary: | summary |