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FDA 510(k)

CV3000 HOLTER ANALYSIS SYSTEM

K-Number: K131897 · 2013-11-26

ApplicantVales & Hills Biomedical Tech. , Ltd.
Decision Date2013-11-26
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CV3000 HOLTER ANALYSIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Vales & Hills Biomedical Tech. , Ltd.. It received FDA 510(k) clearance on 2013-11-26 under 510(k) number K131897. The device is classified under product code MLO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CV3000 HOLTER ANALYSIS SYSTEM?

CV3000 HOLTER ANALYSIS SYSTEM is a medical device that received FDA 510(k) clearance on 2013-11-26. The listed applicant is Vales & Hills Biomedical Tech. , Ltd.. The 510(k) number is K131897.

When did CV3000 HOLTER ANALYSIS SYSTEM receive FDA 510(k) clearance?

CV3000 HOLTER ANALYSIS SYSTEM received FDA 510(k) clearance on 2013-11-26, under 510(k) number K131897.

Who is the listed applicant for CV3000 HOLTER ANALYSIS SYSTEM?

The FDA 510(k) record lists Vales & Hills Biomedical Tech. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CV3000 HOLTER ANALYSIS SYSTEM?

The FDA product code for CV3000 HOLTER ANALYSIS SYSTEM is MLO.

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Other records listing Vales & Hills Biomedical Tech. , Ltd. 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.

K163607ECG Acquisition Systems

Related Devices (Code: MLO)

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.

K261580ZBPro Diagnostic (Version 2.0)Zbeats, Inc.K241890Philips Holter Analysis SystemPhilips Medizin Systeme Böblingen GmbHK240794Frontier X PlusFourth Frontier Technologies Pvt, Ltd.K200833RX-1 Rhythm Express Remote Cardiac Monitoring SystemVivaQuant, Inc.K193177CER-SCardiocalmK182030Faros MobileBittium Biosignals , Ltd.

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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