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FDA 510(k)

D100 KIDS; D101 KIDS

K-Number: K231652 · 2023-11-16

ApplicantSorin Group Italia S.R.L.
Decision Date2023-11-16
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

D100 KIDS; D101 KIDS is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2023-11-16 under approval number K231652. 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 D100 KIDS; D101 KIDS?

D100 KIDS; D101 KIDS is a medical device that received FDA 510(k) clearance on 2023-11-16. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K231652.

When was D100 KIDS; D101 KIDS approved by the FDA?

D100 KIDS; D101 KIDS received FDA 510(k) clearance on 2023-11-16, under approval number K231652.

What company makes D100 KIDS; D101 KIDS?

D100 KIDS; D101 KIDS is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for D100 KIDS; D101 KIDS?

The FDA product code for D100 KIDS; D101 KIDS 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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