FDA 510(k)

PherDal® 在宅精子注入キット

K番号: K231645 · 2023-12-14

決定日2023-12-14

製品コードQYZ

諮問委員会医薬品機器規制テキストの翻訳は以下の通りです。 [原文] OB [翻訳] OB

決定大幅同等

医療機器の概要

PherDal® At-Home Insemination Kit is the device name listed in this FDA 510(k) record. The listed applicant is Pherdal Fertility Science, Inc.. It received FDA 510(k) clearance on 2023-12-14 under 510(k) number K231645. The device is classified under product code QYZ. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the PherDal® At-Home Insemination Kit?

PherDal® At-Home Insemination Kit is a medical device that received FDA 510(k) clearance on 2023-12-14. The listed applicant is Pherdal Fertility Science, Inc.. The 510(k) number is K231645.

When did PherDal® At-Home Insemination Kit receive FDA 510(k) clearance?

PherDal® At-Home Insemination Kit received FDA 510(k) clearance on 2023-12-14, under 510(k) number K231645.

Who is the listed applicant for PherDal® At-Home Insemination Kit?

The FDA 510(k) record lists Pherdal Fertility Science, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PherDal® At-Home Insemination Kit?

The FDA product code for PherDal® At-Home Insemination Kit is QYZ.

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PherDal® 在宅精子注入キット

医療機器の概要

よくある質問

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