The following data is part of a premarket notification filed by Andon Health Co.,ltd with the FDA for Acg-8511 Portable Ecg Monitor.
| Device ID | K110328 |
| 510k Number | K110328 |
| Device Name: | ACG-8511 PORTABLE ECG MONITOR |
| Classification | Electrocardiograph |
| Applicant | ANDON HEALTH CO.,LTD NO 3, JINPING STREET YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
| Contact | Liu Yi |
| Correspondent | Liu Yi ANDON HEALTH CO.,LTD NO 3, JINPING STREET YA AN RD NANKAI DISTRICT Tianjin, CN 300190 |
| Product Code | DPS |
| CFR Regulation Number | 870.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-03 |
| Decision Date | 2011-07-15 |
| Summary: | summary |