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FDA 510(k)

EOS PMP

K-Number: K211495 · 2021-07-12

ApplicantSorin Group Italia S.R.L.
Decision Date2021-07-12
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

EOS PMP is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2021-07-12 under approval number K211495. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EOS PMP?

EOS PMP is a medical device that received FDA 510(k) clearance on 2021-07-12. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K211495.

When was EOS PMP approved by the FDA?

EOS PMP received FDA 510(k) clearance on 2021-07-12, under approval number K211495.

What company makes EOS PMP?

EOS PMP is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for EOS PMP?

The FDA product code for EOS PMP is DTZ.

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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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