The following data is part of a premarket notification filed by Andon Health Co., Ltd. with the FDA for Portable Ecg Monitor (ecg3).
| Device ID | K172862 |
| 510k Number | K172862 |
| Device Name: | Portable ECG Monitor (ECG3) |
| Classification | Recorder, Magnetic Tape, Medical |
| 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 | DSH |
| CFR Regulation Number | 870.2800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-09-20 |
| Decision Date | 2018-07-24 |