The following data is part of a premarket notification filed by Shenzhen Mindray Bio-meidcal Electronics Co., Ltd with the FDA for Hypervisor Central Monitoring System (including Telemetry Monitoring System, Tms-6016).
| Device ID | K132036 |
| 510k Number | K132036 |
| Device Name: | HYPERVISOR CENTRAL MONITORING SYSTEM (INCLUDING TELEMETRY MONITORING SYSTEM, TMS-6016) |
| Classification | System, Network And Communication, Physiological Monitors |
| Applicant | SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD 800 MACARTHUR BLVD. Mahwah, NJ 07430 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen SHENZHEN MINDRAY BIO-MEIDCAL ELECTRONICS CO., LTD 800 MACARTHUR BLVD. Mahwah, NJ 07430 |
| Product Code | MSX |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | MHX |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-01 |
| Decision Date | 2014-07-01 |
| Summary: | summary |