The following data is part of a premarket notification filed by Philips Medizin Systeme Boeblingen Gmbh with the FDA for Intellivue Patient Monitor Mx100 And Multi-measurement Module X3; Intellivue Hemodynamic Extension, Capnography Extension, Microstream Extension;transpac Iv Dual Ibp Cable.
| Device ID | K171801 |
| 510k Number | K171801 |
| Device Name: | IntelliVue Patient Monitor MX100 And Multi-Measurement Module X3; IntelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str.-2 Boeblingen, DE 71034 |
| Contact | Markus Stacha |
| Correspondent | Markus Stacha Philips Medizin Systeme Boeblingen GmbH Hewlett-Packard-Str.-2 Boeblingen, DE 71034 |
| Product Code | MHX |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DRT |
| Subsequent Product Code | DSI |
| Subsequent Product Code | DSJ |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | MLD |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-16 |
| Decision Date | 2017-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838085244 | K171801 | 000 |
| 00884838082595 | K171801 | 000 |
| 00884838082588 | K171801 | 000 |
| 00884838083547 | K171801 | 000 |