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FDA 510(k)

VISTA PLUS

K-Number: K042108 · 2005-01-19

ApplicantNovacor
Decision Date2005-01-19
Product CodeMLO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VISTA PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Novacor. It received FDA 510(k) clearance on 2005-01-19 under 510(k) number K042108. 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 VISTA PLUS?

VISTA PLUS is a medical device that received FDA 510(k) clearance on 2005-01-19. The listed applicant is Novacor. The 510(k) number is K042108.

When did VISTA PLUS receive FDA 510(k) clearance?

VISTA PLUS received FDA 510(k) clearance on 2005-01-19, under 510(k) number K042108.

Who is the listed applicant for VISTA PLUS?

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

What is the FDA product code for VISTA PLUS?

The FDA product code for VISTA PLUS is MLO.

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 Novacor 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.

K040753R-TEST EVOLUTION 3

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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