Philips IntelliVue GuardianSoftware
FDA 510(k) K151736 · Philips Medizin Systeme Boblingen GmbH
510(k) numberK151736
Submission
- Device name
- Philips IntelliVue GuardianSoftware
- Applicant
- Philips Medizin Systeme Boblingen GmbH
Boblingen, DE - Received
- June 26, 2015
- Decision date
- October 21, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXJ – Display, Cathode-Ray Tube, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2450
- Specialty
- Cardiovascular
Other 510(k)s with product code DXJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K212003 | ESSENZ Patient MonitorDXJ · Special | Livanova Deutschland, GmbH | 11/10/2021SE |
| K212208 | Philips IntelliVue GuardianSoftware (Rev. E.0X)DXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 09/30/2021SE |
| K201162 | Essence 55SP Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 08/27/2020SE |
| K173107 | Vios Central Station Monitor Software, Vios Central Server SoftwareDXJ · Traditional | Vios Medical, Inc. | 07/26/2018SE |
| K180534 | Philips IntelliVue GuardianSoftwareDXJ · Traditional | Philips Medizin Systeme Boeblingen GmbH | 07/16/2018SE |
| K173381 | Nexxis ORDXJ · Special | Barco N.V. | 02/22/2018SE |
| K172969 | Essence 55S Large Monitor SystemDXJ · Traditional | Shenyang Torch-Bigtide Digital Technology Co.… | 01/26/2018SE |
| K170460 | Sorin ConnectDXJ · Special | Sorin Group Deutschland GmbH | 06/08/2017SE |
| K170537 | Nexxis OR, NexxisDXJ · Special | Barco N.V. | 04/21/2017SE |
| K161880 | NIVR58-T kitDXJ · Special | Barco N.V. | 03/14/2017SE |
More from Barco N.V.
| 510(k) | Device | Decision |
|---|---|---|
| K140535 | Philips Avalon Fetal / Maternal Monitors FM20, FM30, FM40 and FM50HGM · Abbreviated | 11/25/2014SE |
| K113657 | Intellivue Patient MonitorMHX · Traditional | 03/22/2012SE |
| K102958 | Philips Avalon Fetal MonitorHGM · Traditional | 03/18/2011SE |
| K102562 | Intellivue Patient Monitor, Models MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60…MHX · Special | 10/21/2010SE |
| K090360 | Philips M3001A Multi Measurement ServerDQA · Special | 05/04/2009SE |
| K083228 | Philips Intellivue MP5 Patient MonitorMHX · Special | 11/24/2008SE |
| K060541 | The Philips MP20,MP30,MP40,MP50,MP60,MP70,MP80 and MP90 Intellivue Atient MonitorsMHX · Special | 03/24/2006SE |
| K042845 | The Philips MP20, MP30, MP40, MP50, MP60, MP70, and MP90 Intellivue Patient MonitorsMSX · Special | 11/12/2004SE |
| K032858 | The Philips Intellivue MP40, MP50, MP60, MP70,AND MP90 Patient Monitors, Release B.O.DSI · Special | 10/10/2003SE |
| K031481 | The Philips Intellivue MP60, MP70, and MP90 Patient Monitors, Release A.20MHX · Special | 05/29/2003SE |
Questions and answers
When was Philips IntelliVue GuardianSoftware cleared by the FDA?
Philips IntelliVue GuardianSoftware (K151736) received a 510(k) decision of Substantially Equivalent on October 21, 2015, 117 days after the submission was received.
What is the product code of K151736?
The FDA product code is DXJ – Display, Cathode-Ray Tube, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2450.