FDA 510(k)

KIDScore D3

K-Number: K182798 · 2019-07-19

Decision Date2019-07-19

Product CodePBH

Advisory CommitteeOB

DecisionSubstantially Equivalent

Device Summary

KIDScore D3 is the device name listed in this FDA 510(k) record. The listed applicant is Vitrolife A/S. It received FDA 510(k) clearance on 2019-07-19 under 510(k) 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. The listed applicant is Vitrolife A/S. The 510(k) number is K182798.

When did KIDScore D3 receive FDA 510(k) clearance?

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

Who is the listed applicant for KIDScore D3?

The FDA 510(k) record lists Vitrolife A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for KIDScore D3?

The FDA product code for KIDScore D3 is PBH.

Other records listing Vitrolife A/S as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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