The following data is part of a premarket notification filed by Citizen Watch Co., Ltd. with the FDA for Electronic Digital Blood Pressure Monitor.
Device ID | K923344 |
510k Number | K923344 |
Device Name: | ELECTRONIC DIGITAL BLOOD PRESSURE 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 Androlia |
Correspondent | William 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 | 1992-06-18 |
Decision Date | 1993-10-07 |