Tracer

FDA 510(k) K982617 · Heartland Medical Systems, Inc.

Substantially Equivalent

510(k) numberK982617

Submission

Device name
Tracer
Applicant
Heartland Medical Systems, Inc.
Newbury Park, CA, US
Received
July 27, 1998
Decision date
April 9, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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

Other 510(k)s with product code MWJ

510(k)DeviceApplicantDecision
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

Questions and answers

When was Tracer cleared by the FDA?

Tracer (K982617) received a 510(k) decision of Substantially Equivalent on April 9, 1999, 256 days after the submission was received.

What is the product code of K982617?

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