DMS 300-2, 300-3 and 300-4

FDA 510(k) K062959 · Diagnostic Monitoring Software

Substantially Equivalent

510(k) numberK062959

Submission

Device name
DMS 300-2, 300-3 and 300-4
Applicant
Diagnostic Monitoring Software
Stateline, NV, US
Received
September 29, 2006
Decision date
October 16, 2006
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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K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…MWJ · Traditional Shenzhen Xinyan Medical Technology Co.,ltd.09/11/2026SE
K253529Peerbridge COR MDx (Cor MDx)MWJ · Abbreviated Peerbridge Health, Inc.09/04/2026SE
K253562medilogFDMWJ · Traditional Schiller AG08/14/2026SE
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

More from Medicalgorithmics S.A.

510(k)DeviceDecision
K133014DMS 300-2W Holter ECG RecorderMWJ · Special 05/19/2014SE
K062088Premier 11 HolterMLO · Special 08/25/2006SE
K062007DMS 300-7DSH · Special 08/16/2006SE
K911615Holter 24-HOUR ECG System, Model Number: DMS 300DQK · Traditional 01/08/1992SE

Questions and answers

When was DMS 300-2, 300-3 and 300-4 cleared by the FDA?

DMS 300-2, 300-3 and 300-4 (K062959) received a 510(k) decision of Substantially Equivalent on October 16, 2006, 17 days after the submission was received.

What is the product code of K062959?

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