The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Modification To:fully Automatic Electronic Blood Pressure Monitor, Model Kd-556.
| Device ID | K091500 |
| 510k Number | K091500 |
| Device Name: | MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANDON HEALTH CO.,LTD NO 31, CHANGJIANG ROAD NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON HEALTH CO.,LTD NO 31, CHANGJIANG ROAD NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-21 |
| Decision Date | 2009-07-31 |
| Summary: | summary |