The following data is part of a premarket notification filed by Andon Health Co., Ltd with the FDA for Andon Blood Pressure Cuff.
| Device ID | K133117 |
| 510k Number | K133117 |
| Device Name: | ANDON BLOOD PRESSURE CUFF |
| Classification | Blood Pressure Cuff |
| Applicant | ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON HEALTH CO., LTD No. 3 Jin Ping Street,Ya An Road, NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | DXQ |
| CFR Regulation Number | 870.1120 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-30 |
| Decision Date | 2014-03-04 |
| Summary: | summary |