K092449 is an FDA 510(k) clearance for the BENEVIEW T SERIES PATIENT MONITORS, MODELS BENEVIEW T8, T6 AND T5. This device is classified as a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II - Special Controls, product code MHX).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on August 30, 2010, 385 days after receiving the submission on August 10, 2009.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1025.
| 510(k) Number | K092449 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 10, 2009 |
| Decision Date | August 30, 2010 |
| Days to Decision | 385 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1025 |