PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS— 510(k) K072070
Substantially EquivalentPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
FDA 510(k) clearance K072070 for PHILIPS MP2 AND X2 INTELLIVUE PATIENT MONITORS, Substantially Equivalent on 2007-08-10. Applicant: Philips Medizinsysteme Boeblingen GmbH, Cardiac AN. Device class: 2.
Clearance details
- Applicant
- Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
- Product code
- Code MHX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1025
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Boeblingen, Baden-Wuerttemberg, DE
Recent devices under product code MHX
view allMore clearances from Philips Medizinsysteme Boeblingen GmbH, Cardiac AN
view all- K141015 — INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT
- K132320 — INTELLIVUE CL RESPIRATION POD
- K131872 — INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
- K131829 — INTELLIVUE PATIENT MONITOR
- K130849 — INTELLIVUE PATIENT MONITOR MX400; INTELLIVUE PATIENT MONITOR MX450
Adverse events under product code MHX
product code MHX- Death
- 580
- Injury
- 2,441
- Malfunction
- 12,655
- Other
- 3
- Total
- 15,679
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.