The following data is part of a premarket notification filed by Shenzhen Mindray Bio-medical Electronics Co., Ltd with the FDA for Passport Series Patient Monitors (including Passport 17m, Passport 12m And T1).
| Device ID | K152902 |
| 510k Number | K152902 |
| Device Name: | Passport Series Patient Monitors (including Passport 17m, Passport 12m And T1) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL 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 BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH, HIGH-TECH INDUSTRIAL PARK, NANSHAN Shenzhen, CN 518057 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-01 |
| Decision Date | 2016-02-18 |
| Summary: | summary |