The following data is part of a premarket notification filed by Philips Medizin Systeme Boblingen Gmbh with the FDA for Philips Intellivue Guardiansoftware.
| Device ID | K151736 |
| 510k Number | K151736 |
| Device Name: | Philips IntelliVue GuardianSoftware |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE 71034 |
| Contact | Michael Asmalsky |
| Correspondent | Michael Asmalsky PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH HEWLETT-PACKARD-STR. 2 Boblingen, DE 71034 |
| Product Code | DXJ |
| Subsequent Product Code | DQK |
| Subsequent Product Code | NSX |
| Subsequent Product Code | OUG |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-26 |
| Decision Date | 2015-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838081925 | K151736 | 000 |