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FDA 510(k)

TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM

K-Number: K100155 · 2010-04-20

ApplicantBiomedical Systems Corp.
Decision Date2010-04-20
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomedical Systems Corp.. It received FDA 510(k) clearance on 2010-04-20 under 510(k) number K100155. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM?

TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-20. The listed applicant is Biomedical Systems Corp.. The 510(k) number is K100155.

When did TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM receive FDA 510(k) clearance?

TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM received FDA 510(k) clearance on 2010-04-20, under 510(k) number K100155.

Who is the listed applicant for TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM?

The FDA 510(k) record lists Biomedical Systems Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM?

The FDA product code for TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM is DSI.

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.

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Other records listing Biomedical Systems Corp. as applicant

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.

K024323CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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.

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