K250854

Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)

510(k) number: K250854
Device name: Multi-parameter Patient Monitor (N10); Multi-parameter Patient Monitor (N12); Multi-parameter Patient Monitor (N15); Multi-parameter Patient Monitor (N10MPro); Multi-parameter Patient Monitor (N12MPro); Multi-parameter Patient Monitor (N15MPro)
Applicant: Shenzhen Comen Medical Instruments Co.,Ltd CN
Product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
Decision date: 2025-12-17
Date received: 2025-03-21
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain

Also available from FDA: K250854.pdf

Official FDA record: K250854

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