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 |