K925294 is an FDA 510(k) clearance for the PRECISA. This device is classified as a System, Measurement, Blood-pressure, Non-invasive (Class II - Special Controls, product code DXN).
Submitted by Rudolf Riester GmbH & Co. KG (D-72417 Jungingen, DE). The FDA issued a Cleared decision on February 23, 1994, 490 days after receiving the submission on October 21, 1992.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1130.
| 510(k) Number | K925294 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 21, 1992 |
| Decision Date | February 23, 1994 |
| Days to Decision | 490 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | DXN — System, Measurement, Blood-pressure, Non-invasive |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1130 |