K260098

ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)

510(k) number: K260098
Device name: ePM Series Patient Monitor (ePM 10/ePM 10A/ePM 10C/Guardian plus/ ePM 12/ePM 12A/ePM 12C / ePM 15/ePM 15A/ePM 15C /ePM 10M/ ePM 10MA/ ePM 10MC/ePM 12M/ ePM 12MA/ ePM 12MC/ePM 15M/ ePM 15MA/ ePM 15MC)
Applicant: Shenzhen Mindray Bio-Medical Electronics Co., Ltd. CN
Product code: MHX — Monitor, Physiological, Patient(With Arrhythmia Dete
Decision date: 2026-05-20
Date received: 2026-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: Cardiovascular

510(k) Summary (official FDA PDF): K260098.pdf

Official FDA record: K260098

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