The following data is part of a premarket notification filed by Citizen Watch Co., Ltd. with the FDA for Electronic Digital Blood Pressure/pulse Monitor.
| Device ID | K911965 |
| 510k Number | K911965 |
| Device Name: | ELECTRONIC DIGITAL BLOOD PRESSURE/PULSE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CITIZEN WATCH CO., LTD. 1880 CENTURY PARK EAST SUITE 519 Los Angeles, CA 90067 |
| Contact | William L Androlia |
| Correspondent | William L Androlia CITIZEN WATCH CO., LTD. 1880 CENTURY PARK EAST SUITE 519 Los Angeles, CA 90067 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-02 |
| Decision Date | 1991-10-28 |