DeviceClearance

IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 +2 more— 510(k) K171801

Substantially Equivalent

Philips Medizin Systeme Boeblingen GmbH

FDA 510(k) clearance K171801 for IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3 +2 more, Substantially Equivalent on 2017-10-06. Applicant: Philips Medizin Systeme Boeblingen GmbH. Device class: 2.

Clearance details

Device name as filed
IntelliVue Patient Monitor MX100 and Multi-Measurement Module X3; intelliVue Hemodynamic Extension, Capnography Extension, Microstream Extension;Transpac IV Dual IBP Cable
Applicant
Philips Medizin Systeme Boeblingen 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
Abbreviated
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 →

Recalls naming K171801

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171801.

Data sourced from openFDA. This site is unofficial and independent of the FDA.