Philips IntelliVue GuardianSoftware— 510(k) K151736
Substantially EquivalentPhilips Medizin Systeme Boblingen GmbH
FDA 510(k) clearance K151736 for Philips IntelliVue GuardianSoftware, Substantially Equivalent on 2015-10-21. Applicant: Philips Medizin Systeme Boblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Boblingen GmbH
- Product code
- Product code DXJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.2450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boblingen, DE
Recent devices under product code DXJ
view all- K261469 — Nexxis 2; Nexxis OR 2; NMS 2; MNA-240; MNA-4x0 (Where x may be any numeric character).
- K212003 — ESSENZ Patient Monitor
- K212208 — Philips IntelliVue GuardianSoftware (Rev. E.0X)
- K201162 — Essence 55SP Large Monitor System
- K173107 — Vios Central Station Monitor Software, Vios Central Server Software
More clearances from Philips Medizin Systeme Boblingen GmbH
view all- K140535 — PHILIPS AVALON FETAL / MATERNAL MONITORS FM20, FM30, FM40 AND FM50
- K113657 — INTELLIVUE PATIENT MONITOR
- K102958 — PHILIPS AVALON FETAL MONITOR
- K102562 — INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
- K090360 — PHILIPS M3001A MULTI MEASUREMENT SERVER
Adverse events under product code DXJ
product code DXJ- Death
- 2
- Total
- 2
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.