DMS 300-2W Holter ECG Recorder

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K133014 ↗

FDA Product Code

MWJ

Device Class

Class II

Regulation

21 CFR Part 870.2800

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Dms 300-7

  Class II

  FDA 510(k) K062007 Active Cleared 16 Aug 2006

• Premier 11 Holter

  Class II

  FDA 510(k) K062088 Active Cleared 25 Aug 2006

• Holter 24-Hour ECG System, Model Number: Dms 300

  Class II

  FDA 510(k) K911615 Active Cleared 8 Jan 1992

• Dms 300-2, 300-3 and 300-4

  Class II

  FDA 510(k) K062959 Active Cleared 16 Oct 2006

• What is the DMS 300-2W Holter ECG Recorder used for?

  The DMS 300-2W Holter ECG Recorder is designed for continuous monitoring of cardiac activity in ambulatory or clinical settings, capturing multi-lead ECG signals via electrode cables to record heart rhythm over time for diagnostic evaluation.

• How is the DMS 300-2W Holter ECG Recorder powered and what data storage does it use?

  The device is battery-powered and stores captured ECG data on internal memory chips, allowing for continuous recording without external power during use.

• Does the DMS 300-2W Holter ECG Recorder include features for marking symptoms or checking electrode quality?

  Yes, it features an event button for patients to mark symptomatic episodes and auxiliary outputs including USB and WiFi to enable real-time monitoring of electrode quality or operational status during use.

• Is the DMS 300-2W Holter ECG Recorder intended for single-use or repeated use?

  The device is supplied as a reusable system intended for multiple uses in clinical or ambulatory environments, with proper cleaning and maintenance between patients as per manufacturer guidelines.

• What regulatory pathway was used for the DMS 300-2W Holter ECG Recorder?

  The device received authorization via FDA 510(k) clearance under submission K133014, indicating it was found substantially equivalent to a legally marketed predicate device.