The following data is part of a premarket notification filed by Philips Medizinsysteme Boeblingen Gmbh, Cardiac An with the FDA for Intellivue Guardian Software Model 866009, Intellivue Cl Sp02 Pod Model 865215, Intellivue Cl Nbp Pod Model 865216.
| Device ID | K111905 |
| 510k Number | K111905 |
| Device Name: | INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 |
| Classification | Display, Cathode-ray Tube, Medical |
| 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 | DXJ |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRG |
| Subsequent Product Code | DRQ |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSA |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DSK |
| Subsequent Product Code | DXG |
| Subsequent Product Code | DXN |
| Subsequent Product Code | DXQ |
| Subsequent Product Code | MSX |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-05 |
| Decision Date | 2011-10-04 |
| Summary: | summary |