The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Hypervisor Ix Monitoring System.
| Device ID | K150632 |
| 510k Number | K150632 |
| Device Name: | Hypervisor IX Monitoring System |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KENJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK, NANSHAN Shenzhen, CN 518057 |
| Contact | Yanhong Bai |
| Correspondent | Yanhong Bai SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KENJI 12TH ROAD SOUTH, HI-TECH INDUSTRIAL PARK, NANSHAN Shenzhen, CN 518057 |
| Product Code | MSX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-07-06 |
| Summary: | summary |