The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Kd-591 Fully Automatic Electronic Blood Pressure Monitor.
| Device ID | K080319 |
| 510k Number | K080319 |
| Device Name: | KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANDON HEALTH CO.,LTD NO. 10 JINPING ROAD YAAN ROAD NANKAI DISTRICT Tiajin, CN 300190 |
| Contact | Ms. Mona |
| Correspondent | Ms. Mona ANDON HEALTH CO.,LTD NO. 10 JINPING ROAD YAAN ROAD NANKAI DISTRICT Tiajin, CN 300190 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-06 |
| Decision Date | 2008-07-02 |
| Summary: | summary |