The following data is part of a premarket notification filed by Kodon(tianjin)electronic&electrical Apparatus Co., with the FDA for Kd-595 Fully Automatic Electronic Blood Pressure Monitor.
| Device ID | K070828 |
| 510k Number | K070828 |
| Device Name: | KD-595 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., NO.31, CHANGJIANG ROAD, NANKAI DISTRICT Tianjin, CN 300193 |
| Contact | Liu Yi |
| Correspondent | Liu Yi KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., NO.31, CHANGJIANG ROAD, NANKAI DISTRICT Tianjin, CN 300193 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-26 |
| Decision Date | 2007-08-15 |
| Summary: | summary |