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FDA 510(k)

LVIVO EF SYSTEM

K-Number: K130779 · 2013-08-15

ApplicantDiacardio, Ltd.
Decision Date2013-08-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

LVIVO EF SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Diacardio, Ltd.. It received FDA 510(k) clearance on 2013-08-15 under 510(k) number K130779. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LVIVO EF SYSTEM?

LVIVO EF SYSTEM is a medical device that received FDA 510(k) clearance on 2013-08-15. The listed applicant is Diacardio, Ltd.. The 510(k) number is K130779.

When did LVIVO EF SYSTEM receive FDA 510(k) clearance?

LVIVO EF SYSTEM received FDA 510(k) clearance on 2013-08-15, under 510(k) number K130779.

Who is the listed applicant for LVIVO EF SYSTEM?

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

What is the FDA product code for LVIVO EF SYSTEM?

The FDA product code for LVIVO EF SYSTEM is LLZ.

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 Diacardio, 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.

K161382LVivo Software Application

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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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