K110328 is an FDA 510(k) clearance for the ACG-8511 PORTABLE ECG MONITOR. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Andon Health Co, Ltd. (Tianjin, CN). The FDA issued a Cleared decision on July 15, 2011, 162 days after receiving the submission on February 3, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K110328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 03, 2011 |
| Decision Date | July 15, 2011 |
| Days to Decision | 162 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPS — Electrocardiograph |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2340 |