The following data is part of a premarket notification filed by Andon Medical Co., Ltd. with the FDA for Kd-5966 Series Fully Automatic Electronic Blood Pressure Monitor.
| Device ID | K102609 |
| 510k Number | K102609 |
| Device Name: | KD-5966 SERIES FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANDON MEDICAL CO., LTD. # 3 JIN PING STREET, YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON MEDICAL CO., LTD. # 3 JIN PING STREET, YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2010-12-09 |
| Summary: | summary |