Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TRACER

K-Number: K982617 · 1999-04-09

ApplicantHeartland Medical Systems, Inc.
Decision Date1999-04-09
Product CodeMWJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRACER is the device name listed in this FDA 510(k) record. The listed applicant is Heartland Medical Systems, Inc.. It received FDA 510(k) clearance on 1999-04-09 under 510(k) number K982617. The device is classified under product code MWJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACER?

TRACER is a medical device that received FDA 510(k) clearance on 1999-04-09. The listed applicant is Heartland Medical Systems, Inc.. The 510(k) number is K982617.

When did TRACER receive FDA 510(k) clearance?

TRACER received FDA 510(k) clearance on 1999-04-09, under 510(k) number K982617.

Who is the listed applicant for TRACER?

The FDA 510(k) record lists Heartland Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRACER?

The FDA product code for TRACER is MWJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: MWJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable ECG Recorder (YMHeart XY-1202); Wearable ECG Recorder (YMHeart XY-1203); Wearable ECG Recorder (YMHeart XY-03); Wearable ECG Recorder (YMHeart XY-0301); Wearable ECG Recorder (YMHeart XY-0302); Wearable ECG Recorder (YMHeart XY-0303)Shenzhen Xinyan Medical Technology Co.,ltd.K253529Peerbridge COR MDx (Cor MDx)Peerbridge Health, Inc.K253562medilogFDSchiller AGK253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7, mobiCARE-MC200ML7)Seers Technology Co., Ltd.K252839ZywieZ3 Sensor & AdhesiveZywie, Inc.K231424HeartBeam AIMIGo(TM) SystemHeartbeam, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑