The following data is part of a premarket notification filed by Citizen Watch Co., Ltd. with the FDA for Ch-502a & Ch520b Digital Finger Sphygmomanometer.
| Device ID | K954547 |
| 510k Number | K954547 |
| Device Name: | CH-502A & CH520B DIGITAL FINGER SPHYGMOMANOMETER |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | CITIZEN WATCH CO., LTD. 555 13TH STREET, N.W. Washington, DC 20004 |
| Contact | Howard M Holstein |
| Correspondent | Howard M Holstein CITIZEN WATCH CO., LTD. 555 13TH STREET, N.W. Washington, DC 20004 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-29 |
| Decision Date | 1997-04-01 |
| Summary: | summary |