The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Semi-fully Automatic Electronic Blood Pressure Monitor, Models: Kd-322,kd-622,kd-575,kd-525e,kd-593,kd-595,kd-596,kd-598.
| Device ID | K083395 |
| 510k Number | K083395 |
| Device Name: | SEMI-FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS: KD-322,KD-622,KD-575,KD-525E,KD-593,KD-595,KD-596,KD-598 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANDON HEALTH CO.,LTD NO 31, CHANGJIANG ROAD NANKAI DISTRICT Tianjin, CN 300193 |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON HEALTH CO.,LTD NO 31, CHANGJIANG ROAD NANKAI DISTRICT Tianjin, CN 300193 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-17 |
| Decision Date | 2009-02-27 |
| Summary: | summary |