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FDA 510(k)

EmbryoSlide+ ic8 dish

K-Number: K213869 · 2022-03-11

ApplicantVitrolife A/S
Decision Date2022-03-11
Product CodeMQK
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

EmbryoSlide+ ic8 dish 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 2022-03-11 under 510(k) number K213869. The device is classified under product code MQK. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EmbryoSlide+ ic8 dish?

EmbryoSlide+ ic8 dish is a medical device that received FDA 510(k) clearance on 2022-03-11. The listed applicant is Vitrolife A/S. The 510(k) number is K213869.

When did EmbryoSlide+ ic8 dish receive FDA 510(k) clearance?

EmbryoSlide+ ic8 dish received FDA 510(k) clearance on 2022-03-11, under 510(k) number K213869.

Who is the listed applicant for EmbryoSlide+ ic8 dish?

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 EmbryoSlide+ ic8 dish?

The FDA product code for EmbryoSlide+ ic8 dish is MQK.

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.

K182798KIDScore D3K173264EmbryoScope+

Related Devices (Code: MQK)

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

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