The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Philips Intellivue Guardiansoftware (rev. E.0x).
| Device ID | K212208 |
| 510k Number | K212208 |
| Device Name: | Philips IntelliVue GuardianSoftware (Rev. E.0X) |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen, DE 71034 |
| Contact | Johannes Schmid |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DXJ |
| CFR Regulation Number | 870.2450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2021-07-15 |
| Decision Date | 2021-09-30 |