K250453
- 510(k) number
- K250453
- Device name
- IntelliVue Patient Monitor 6100 (6100); IntelliVue Patient Monitor 6300 (6300); IntelliVue Patient Monitor 6500 (6500)
- Applicant
- Philips Medizin Systeme Böblingen GmbH DE
- Product code
- MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
- Decision date
- 2025-09-02
- Date received
- 2025-02-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K250453.pdf
Official FDA record: K250453
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.