The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Philips Intellivue Xds Software.
| Device ID | K182637 |
| 510k Number | K182637 |
| Device Name: | Philips IntelliVue XDS Software |
| Classification | System, Network And Communication, Physiological Monitors |
| 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 | MSX |
| Subsequent Product Code | DSH |
| Subsequent Product Code | NSX |
| Subsequent Product Code | OUG |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-24 |
| Decision Date | 2019-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838092099 | K182637 | 000 |