THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90— 510(k) K061052

Substantially Equivalent

Philips Medical Systems North America, Inc.

FDA 510(k) clearance K061052 for THE PHILIPS INTELLIVUE PATIENT MONITORS, MODELS MP20,MP30,MP40,MP50,MP60,MP70,MP80,MP90, Substantially Equivalent on 2006-05-26. Applicant: Philips Medical Systems North America, Inc.. Device class: 2.

Clearance details

Applicant
Philips Medical Systems North America, Inc.
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, DE
Download summary PDFView on FDA.gov ↗

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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.