The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Philips Intellivue Guardiansoftware.
| Device ID | K180534 |
| 510k Number | K180534 |
| Device Name: | Philips IntelliVue GuardianSoftware |
| Classification | Display, Cathode-ray Tube, Medical |
| Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen, DE 71034 |
| Contact | Michael Asmalsky |
| Correspondent | Michael Asmalsky Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard Str. 2 Boeblingen, 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-28 |
| Decision Date | 2018-07-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838085718 | K180534 | 000 |