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 8, Passport 12).
| Device ID | K153448 |
| 510k Number | K153448 |
| Device Name: | Passport Series Patient Monitors (Including Passport 8, Passport 12) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH HI-TECH INDUSTRIAL PARK, NANSHAN Nanshan, CN 518057 |
| Contact | Bai Yanhong |
| Correspondent | Bai Yanhong SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD MINDRAY BUILDING, KEJI 12TH ROAD SOUTH HI-TECH INDUSTRIAL PARK, NANSHAN Nanshan, 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 | 2015-11-30 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904090917 | K153448 | 000 |
| 06944904006475 | K153448 | 000 |
| 06944904085692 | K153448 | 000 |
| 06944904085708 | K153448 | 000 |
| 06944904086019 | K153448 | 000 |
| 06944904086026 | K153448 | 000 |
| 06944904086033 | K153448 | 000 |
| 06944904086040 | K153448 | 000 |
| 06944904086071 | K153448 | 000 |
| 06944904086088 | K153448 | 000 |
| 06944904086095 | K153448 | 000 |
| 06944904086101 | K153448 | 000 |
| 06944904086118 | K153448 | 000 |
| 06944904086125 | K153448 | 000 |
| 06944904090900 | K153448 | 000 |
| 06944904004631 | K153448 | 000 |