Cleared Traditional

Holter ECG and ABP System

K230184 · Edan Instruments, Inc. · Cardiovascular
Sep 2023
Decision
245d
Days
Class 2
Risk

About This 510(k) Submission

K230184 is an FDA 510(k) clearance for the Holter ECG and ABP System, a Recorder, Magnetic Tape, Medical (Class II — Special Controls, product code DSH), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on September 25, 2023, 245 days after receiving the submission on January 23, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2800.

Submission Details

510(k) Number K230184 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2023
Decision Date September 25, 2023
Days to Decision 245 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DSH — Recorder, Magnetic Tape, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.2800

More from Edan Instruments, Inc.

View all
Holter ECG and ABP system (HolterABP)
K251591 · DQK · Feb 2026
Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)
K251268 · IYN · Dec 2025
Fetal & Maternal Monitor (F15A, F15A Air)
K241882 · HGM · Aug 2025
Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)
K250179 · MHX · Jul 2025
Acclarix AX8 Series Diagnostic Ultrasound System (Model: Acclarix AX7, Acclarix AX8, Acclarix AX75, Acclarix AX78, Acclarix AX8 Exp, Acclarix AX8 Super), Acclarix AX9 Series Diagnostic Ultrasound Szystem (Model: Acclarix AX9 Basic, Acclarix AX9, Acclarix AX9 Exp, Acclarix AX9 Super, Acclarix AX85, Acclarix AX88)
K250214 · IYN · Feb 2025