K013205 is an FDA 510(k) clearance for the MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000. This device is classified as a Amplifier And Signal Conditioner, Transducer Signal (Class II - Special Controls, product code DRQ).
Submitted by Millar Instruments, Inc. (Houston, US). The FDA issued a Cleared decision on July 2, 2002, 280 days after receiving the submission on September 25, 2001.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2060.
| 510(k) Number | K013205 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2001 |
| Decision Date | July 02, 2002 |
| Days to Decision | 280 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DRQ — Amplifier And Signal Conditioner, Transducer Signal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2060 |