The following data is part of a premarket notification filed by Shenzhen Mindray Biomedical Electronics Co. Ltd with the FDA for Passport Series Patient Monitors.
| Device ID | K132662 |
| 510k Number | K132662 |
| Device Name: | PASSPORT SERIES PATIENT MONITORS |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HIGH-TECH INDUSTRIAL PARK Nanshan, Shenzhen, CN 518057 |
| Contact | Yanhong Bai |
| Correspondent | Yanhong Bai SHENZHEN MINDRAY BIOMEDICAL ELECTRONICS CO. LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HIGH-TECH INDUSTRIAL PARK Nanshan, Shenzhen, CN 518057 |
| Product Code | MHX |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DPZ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2014-08-01 |
| Summary: | summary |