THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS— 510(k) K060541
Substantially EquivalentPhilips Medizin Systeme Boblingen GmbH
FDA 510(k) clearance K060541 for THE PHILIPS MP20,MP30,MP40,MP50,MP60,MP70,MP80 AND MP90 INTELLIVUE ATIENT MONITORS, Substantially Equivalent on 2006-03-24. Applicant: Philips Medizin Systeme Boblingen GmbH. Device class: 2.
Clearance details
- Applicant
- Philips Medizin Systeme Boblingen GmbH
- 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
- Boblingen, DE
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- K102562 — INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800
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.