The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Hypervisor Vi Central Monitoring System (including Tms).
| Device ID | K080192 |
| 510k Number | K080192 |
| Device Name: | HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein |
| Correspondent | Susan D Goldstein SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD 55 NORTHERN BLVD., SUITE 200 Great Neck, NY 11021 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-25 |
| Decision Date | 2008-04-03 |
| Summary: | summary |