← Product Code [MHX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX) · 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) (K260098)

_Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · MHX · May 20, 2026 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K260098

## Device Facts

- **Applicant:** Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- **Product Code:** [MHX](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX.md)
- **Decision Date:** May 20, 2026
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 870.1025
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular

## Regulatory Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

## Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

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**Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K260098](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/MHX/K260098)

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