DMS 300-2W HOLTER ECG RECORDER— 510(k) K133014

Name: FDA 510(k) clearance K133014
Creator: U.S. Food and Drug Administration
Published: 2014-05-19

Substantially Equivalent

Diagnostic Monitoring Software

FDA 510(k) clearance K133014 for DMS 300-2W HOLTER ECG RECORDER, Substantially Equivalent on 2014-05-19. Applicant: Diagnostic Monitoring Software. Device class: 2.

Clearance details

Applicant: Diagnostic Monitoring Software
Product code: Code MWJ
Device class: Class 2
Regulation: 21 CFR 870.2800
Advisory panel: Cardiovascular
Date received: 2013-09-25
Decision date: 2014-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Stateline, NV, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MWJ

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K253562 — medilogFD2026-08-14
K253384 — mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)2026-06-25
K252839 — ZywieZ3 Sensor & Adhesive2026-06-18
K231424 — HeartBeam AIMIGo(TM) System2024-12-13
K233864 — ASSURE Wearable ECG2024-05-07

More clearances from Diagnostic Monitoring Software

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K062959 — DMS 300-2, 300-3 AND 300-42006-10-16
K062088 — PREMIER 11 HOLTER2006-08-25
K062007 — DMS 300-72006-08-16
K911615 — HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 3001992-01-08

Adverse events under product code MWJ

product code MWJ

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.