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FDA 510(k)

KIDScore D3

K-Number: K182798 · 2019-07-19

ApplicantVitrolife A/S
Decision Date2019-07-19
Product CodePBH
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

KIDScore D3 is a medical device manufactured by Vitrolife A/S. It received FDA 510(k) clearance on 2019-07-19 under approval number K182798. The device is classified under product code PBH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KIDScore D3?

KIDScore D3 is a medical device that received FDA 510(k) clearance on 2019-07-19. It is manufactured by Vitrolife A/S. The 510(k) number is K182798.

When was KIDScore D3 approved by the FDA?

KIDScore D3 received FDA 510(k) clearance on 2019-07-19, under approval number K182798.

What company makes KIDScore D3?

KIDScore D3 is manufactured by Vitrolife A/S.

What is the FDA product code for KIDScore D3?

The FDA product code for KIDScore D3 is PBH.

Other Devices by Vitrolife A/S

Related Devices (Code: PBH)

Official Source

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