IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension— 510(k) K181314
Substantially EquivalentPhilips Medizin Systeme Boeblingen GmbH
FDA 510(k) clearance K181314 for IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension, Substantially Equivalent on 2018-09-04. Applicant: Philips Medizin Systeme Boeblingen GmbH.
Clearance details
- Applicant
- Philips Medizin Systeme Boeblingen GmbH
- Product code
- Code MHX
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Böblingen, DE
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.