The following data is part of a premarket notification filed by Citizen Watch Co., Ltd. with the FDA for Ch-601a And Ch-601b Digital Wrist Sphygmomanometer (ch-601a/ch-601b).
| Device ID | K973061 |
| 510k Number | K973061 |
| Device Name: | CH-601A AND CH-601B DIGITAL WRIST SPHYGMOMANOMETER (CH-601A/CH-601B) |
| 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 | 1997-08-18 |
| Decision Date | 1998-03-13 |
| Summary: | summary |