IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) (K221348)
Description
IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) by Philips Medizin Systeme Böblingen GmbH, an FDA 510(k) cleared cardiovascular device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K221348
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. IntelliVue Patient Monitor MX750 (866471);IntelliVue Patient Monitor MX850 (866470) (K221348) cites 5 predicate devices and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K210906 | IntelliVue Patient Monitor MX750, IntelliVue Patient Monito... | Philips Medizin Systeme Boeblingen ... | 2021 |
| K172890 | SedLine Sedation Monitor | Masimo Corporation | 2018 |
| K171121 | Masimo Root Monitoring System and Accessories | Masimo Corporation | 2017 |
| K162603 | Masimo O3 Regional Oximeter System | Masimo Corporation | 2017 |
| K123043 | IRMA C02 MODEL 200101; IRMA AX 200601 | Phasein AB | 2012 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K231671 | IntelliVue Patient Monitor MX750 (866471), IntelliVue Patie... | Philips Medizin Systeme Boeblingen ... | 2023 |
Trace the full predicate network for K221348
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.