The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Kd-936 Fully Automatic Wireless Blood Pressure Monitor.
| Device ID | K120672 |
| 510k Number | K120672 |
| Device Name: | KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | ANDON HEALTH CO.,LTD 116 VILLAGE BOULEVARD SUITE 200 Princeton, NJ 08540 |
| Contact | Thomas Becze |
| Correspondent | Thomas Becze ANDON HEALTH CO.,LTD 116 VILLAGE BOULEVARD SUITE 200 Princeton, NJ 08540 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-03-05 |
| Decision Date | 2012-06-01 |
| Summary: | summary |