K102767 is an FDA 510(k) clearance for the CARDIO XP. This device is classified as a Electrocardiograph (Class II - Special Controls, product code DPS).
Submitted by Bionet Co., Ltd. (Irvine, US). The FDA issued a Cleared decision on June 3, 2011, 252 days after receiving the submission on September 24, 2010.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2340.
| 510(k) Number | K102767 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 24, 2010 |
| Decision Date | June 03, 2011 |
| Days to Decision | 252 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 |