K123095 is an FDA 510(k) clearance for the MEDLINE BLOOD PRESSURE TRANSDUCER. This device is classified as a Transducer, Blood-pressure, Extravascular (Class II - Special Controls, product code DRS).
Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on May 8, 2013, 218 days after receiving the submission on October 2, 2012.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2850.
| 510(k) Number | K123095 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 02, 2012 |
| Decision Date | May 08, 2013 |
| Days to Decision | 218 days |
| Submission Type | Abbreviated |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRS — Transducer, Blood-pressure, Extravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2850 |