INTELLIVUE CLINICAL INFORMATION PORTFOLIO— 510(k) K100272
Substantially EquivalentPhilips Medical Systems
FDA 510(k) clearance K100272 for INTELLIVUE CLINICAL INFORMATION PORTFOLIO, Substantially Equivalent on 2010-04-14. Applicant: Philips Medical Systems. Device class: 2.
Clearance details
- Applicant
- Philips Medical Systems
- 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
- Andover, MA, US
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 Medical Systems
view all- K212704 — Philips EPIQ Diagnostic Ultrasound System, Philips Affiniti Diagnostic Ultrasound System
- K211597 — EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System
- K210560 — Page Writer TC20 Cardiograph, Page Writer TC30 Cardiograph, Page Writer TC50 Cardiograph, Page Writer TC70 Cardiograph
- K191738 — PageWriter TC20 Cardiograph, PageWriter TC30 Cardiograph, PageWriter TC50 Cardiograph, PageWriter TC70 Cardiograph
- K192875 — Philips Biosensor BX100
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.