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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 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 2023-11-16 under 510(k) 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. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K231652.

When did D100 KIDS; D101 KIDS receive FDA 510(k) clearance?

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

Who is the listed applicant for D100 KIDS; D101 KIDS?

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 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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