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FDA 510(k)

VIVI ERGON-X HF

K-Number: K120318 · 2012-03-06

ApplicantVivi S.R.L.
Decision Date2012-03-06
Product CodeMUH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VIVI ERGON-X HF is the device name listed in this FDA 510(k) record. The listed applicant is Vivi S.R.L.. It received FDA 510(k) clearance on 2012-03-06 under 510(k) number K120318. The device is classified under product code MUH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VIVI ERGON-X HF?

VIVI ERGON-X HF is a medical device that received FDA 510(k) clearance on 2012-03-06. The listed applicant is Vivi S.R.L.. The 510(k) number is K120318.

When did VIVI ERGON-X HF receive FDA 510(k) clearance?

VIVI ERGON-X HF received FDA 510(k) clearance on 2012-03-06, under 510(k) number K120318.

Who is the listed applicant for VIVI ERGON-X HF?

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

What is the FDA product code for VIVI ERGON-X HF?

The FDA product code for VIVI ERGON-X HF is MUH.

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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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