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FDA 510(k)

MEMO 4D

K-Number: K180411 · 2018-03-16

ApplicantSorin Group Italia S.R.L.
Decision Date2018-03-16
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MEMO 4D is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2018-03-16 under 510(k) number K180411. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEMO 4D?

MEMO 4D is a medical device that received FDA 510(k) clearance on 2018-03-16. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K180411.

When did MEMO 4D receive FDA 510(k) clearance?

MEMO 4D received FDA 510(k) clearance on 2018-03-16, under 510(k) number K180411.

Who is the listed applicant for MEMO 4D?

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

What is the FDA product code for MEMO 4D?

The FDA product code for MEMO 4D is KRH.

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Official Source

View on FDA Database →

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

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