The following data is part of a premarket notification filed by Mindray Ds Usa, Inc. with the FDA for Endeavour Monitoring System.
| Device ID | K102004 |
| 510k Number | K102004 |
| Device Name: | ENDEAVOUR MONITORING SYSTEM |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | MINDRAY DS USA, INC. 800 MACARTHUR BLVD Mahwah, NJ 07430 |
| Contact | Russell Olsen |
| Correspondent | Russell Olsen MINDRAY DS USA, INC. 800 MACARTHUR BLVD Mahwah, NJ 07430 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-15 |
| Decision Date | 2010-09-10 |
| Summary: | summary |