K111542 is an FDA 510(k) clearance for the DELTEX MEDICAL CARDIOQ EDM. This device is classified as a Flowmeter, Blood, Cardiovascular (Class II - Special Controls, product code DPW).
Submitted by Deltex Medical Limited (Hertsfordshire, GB). The FDA issued a Cleared decision on October 20, 2011, 140 days after receiving the submission on June 2, 2011.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2100.
| 510(k) Number | K111542 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 02, 2011 |
| Decision Date | October 20, 2011 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DPW — Flowmeter, Blood, Cardiovascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2100 |