K251146
- 510(k) number
- K251146
- Device name
- IntelliVue Patient monitors MX400, MX450, MX500, MX550
- Applicant
- Philips Medizin Systeme Boeblingen GmbH DE
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2025-10-17
- Date received
- 2025-04-14
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K251146.pdf
Official FDA record: K251146
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.