K090895 is an FDA 510(k) clearance for the EKG-PLUS II SOFTWARE..
Submitted by Bionet Co., Ltd. (-Gu, Seoul, KR). The FDA issued a Cleared decision on August 26, 2009, 149 days after receiving the submission on March 30, 2009.
This device falls under the Cardiovascular FDA review panel.
| 510(k) Number | K090895 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2009 |
| Decision Date | August 26, 2009 |
| Days to Decision | 149 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LOS |
| Device Class | - |