Mr. Gan · haixiao@sungolytest.com · +86 158 2169 5110 · +86 132 4819 8029Mr. Luo · jun.luo@sungoglobal.com · +86 177 5560 4650

K230604

IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)

510(k) number
K230604
Device name
IntelliVue Patient Monitor MX100 (867033), IntelliVue Multi-Measurement Module X3 (867030)
Applicant
Philips Medizin Systeme Boeblingen GmbH DE
Product code
MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
Decision date
2023-11-22
Date received
2023-03-03
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Cardiovascular
PDFDownload 510(k) SummaryArchived here · 1.5 MB · U.S. public domain

Also available from FDA: K230604.pdf

Official FDA record: K230604
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.