The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Patient Monitor Mx400; Intellivue Patient Monitor Mx450.
| Device ID | K130849 |
| 510k Number | K130849 |
| Device Name: | INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450 |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Contact | Markus Stacha |
| Correspondent | Markus Stacha PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN HEWLETT-PACKARD STR.2 Boeblingen, DE D 71034 |
| Product Code | MHX |
| Subsequent Product Code | BZC |
| Subsequent Product Code | BZQ |
| Subsequent Product Code | CBQ |
| Subsequent Product Code | CBR |
| Subsequent Product Code | CBS |
| Subsequent Product Code | CCK |
| Subsequent Product Code | CCL |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRJ |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | DRS |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DRW |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSB |
| Subsequent Product Code | DSF |
| Subsequent Product Code | DSH |
| Subsequent Product Code | DSI |
| Subsequent Product Code | &nb |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2013-06-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838038769 | K130849 | 000 |
| 00884838038752 | K130849 | 000 |