The following data is part of a premarket notification filed by Mindray North America with the FDA for Passport M Series Patient Monitoring (including Models Passport 17m And Passport 12m).
| Device ID | K132075 |
| 510k Number | K132075 |
| Device Name: | PASSPORT M SERIES PATIENT MONITORING (INCLUDING MODELS PASSPORT 17M AND PASSPORT 12M) |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | MINDRAY NORTH AMERICA 800 MACARTHUR BLVD Mahwah, NJ 07430 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen MINDRAY NORTH AMERICA 800 MACARTHUR BLVD Mahwah, NJ 07430 |
| Product Code | MHX |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-07-03 |
| Decision Date | 2014-04-18 |
| Summary: | summary |