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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 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 2021-07-12 under 510(k) 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. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K211495.

When did EOS PMP receive FDA 510(k) clearance?

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

Who is the listed applicant for EOS PMP?

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 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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