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FDA 510(k)

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

K-Number: K024323 · 2003-06-30

ApplicantBiomedical Systems Corp.
Decision Date2003-06-30
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 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 2003-06-30 under 510(k) number K024323. 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 CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000?

CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 is a medical device that received FDA 510(k) clearance on 2003-06-30. The listed applicant is Biomedical Systems Corp.. The 510(k) number is K024323.

When did CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 receive FDA 510(k) clearance?

CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 received FDA 510(k) clearance on 2003-06-30, under 510(k) number K024323.

Who is the listed applicant for CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000?

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 CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000?

The FDA product code for CENTURY SERIES HOLTER SCANNER SYSTEM, MODELS C3000, C2000 AND C1000 is MLO.

Related Clinical Trials

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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.

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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

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

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