FDA 510(k)

LVivo Software Application

K-Number: K161382 · 2016-07-28

Decision Date2016-07-28

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

LVivo Software Application is the device name listed in this FDA 510(k) record. The listed applicant is Diacardio, Ltd.. It received FDA 510(k) clearance on 2016-07-28 under 510(k) number K161382. 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 Software Application?

LVivo Software Application is a medical device that received FDA 510(k) clearance on 2016-07-28. The listed applicant is Diacardio, Ltd.. The 510(k) number is K161382.

When did LVivo Software Application receive FDA 510(k) clearance?

LVivo Software Application received FDA 510(k) clearance on 2016-07-28, under 510(k) number K161382.

Who is the listed applicant for LVivo Software Application?

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 Software Application?

The FDA product code for LVivo Software Application is LLZ.

Related Devices (Code: LLZ)

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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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.