K051897 is an FDA 510(k) clearance for the TRIO MONITOR. This device is classified as a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MWI).
Submitted by Datascope Corp. (Mahwh, US). The FDA issued a Cleared decision on August 12, 2005, 30 days after receiving the submission on July 13, 2005.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K051897 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2005 |
| Decision Date | August 12, 2005 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Statement |
| Product Code | MWI - Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |