K120624 is an FDA 510(k) clearance for the ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT). This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Elcam Medical Acal (Kibbutz Baram, IL). The FDA issued a Cleared decision on June 8, 2012, 99 days after receiving the submission on March 1, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K120624 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 01, 2012 |
| Decision Date | June 08, 2012 |
| Days to Decision | 99 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRS - Transducer, Blood-pressure, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2850 |