DMS 300-2W Holter ECG Recorder

FDA 510(k) K133014 · Diagnostic Monitoring Software

Substantially Equivalent

510(k) numberK133014

Submission

Device name
DMS 300-2W Holter ECG Recorder
Applicant
Diagnostic Monitoring Software
Stateline, NV, US
Received
September 25, 2013
Decision date
May 19, 2014
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MWJ – Electrocardiograph, Ambulatory (Without Analysis)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Specialty
Cardiovascular

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K253529Peerbridge COR MDx (Cor MDx)MWJ · Abbreviated Peerbridge Health, Inc.09/04/2026SE
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K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…MWJ · Traditional Seers Technology Co., Ltd.06/25/2026SE
K252839ZywieZ3 Sensor & AdhesiveMWJ · Traditional Zywie, Inc.06/18/2026SE
K231424HeartBeam AIMIGo(TM) SystemMWJ · Traditional Heartbeam, Inc.12/13/2024SE
K233864ASSURE Wearable ECGMWJ · Traditional Kestra Medical Technologies, Inc.05/07/2024SE
K212317Eclipse MINI Model 98900MWJ · Traditional Spacelabs Healthcare, Ltd.11/07/2022SE
K222017BiotresMWJ · Special Biotricity07/28/2022SE
K210758Q PatchMWJ · Traditional Medicalgorithmics S.A.06/02/2022SE

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K062007DMS 300-7DSH · Special 08/16/2006SE
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Questions and answers

When was DMS 300-2W Holter ECG Recorder cleared by the FDA?

DMS 300-2W Holter ECG Recorder (K133014) received a 510(k) decision of Substantially Equivalent on May 19, 2014, 236 days after the submission was received.

What is the product code of K133014?

The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.