K080192 is an FDA 510(k) clearance for the HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS). This device is classified as a System, Network And Communication, Physiological Monitors (Class II - Special Controls, product code MSX).
Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on April 3, 2008, 69 days after receiving the submission on January 25, 2008.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.2300.
| 510(k) Number | K080192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 25, 2008 |
| Decision Date | April 03, 2008 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MSX — System, Network And Communication, Physiological Monitors |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.2300 |