INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT— 510(k) K141015
Substantially EquivalentPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN
FDA 510(k) clearance K141015 for INTELLIVUE PATIENT MONITOR MX400, INTELLIVUE PATIENT MONITOR MX450, INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT, Substantially Equivalent on 2014-05-19. 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 allAdverse 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 →
Recalls naming K141015
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K141015.
Data sourced from openFDA. This site is unofficial and independent of the FDA.