FDA 510(k)

胎児ドプラー

K番号: K182190 · 2018-12-19

申請者Shenzhen AOJ Medical Technology Co., Ltd.

決定日2018-12-19

製品コードKNG

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

Fetal Doppler is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2018-12-19 under 510(k) number K182190. The device is classified under product code KNG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Fetal Doppler?

Fetal Doppler is a medical device that received FDA 510(k) clearance on 2018-12-19. The listed applicant is Shenzhen AOJ Medical Technology Co., Ltd.. The 510(k) number is K182190.

When did Fetal Doppler receive FDA 510(k) clearance?

Fetal Doppler received FDA 510(k) clearance on 2018-12-19, under 510(k) number K182190.

Who is the listed applicant for Fetal Doppler?

The FDA 510(k) record lists Shenzhen AOJ Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fetal Doppler?

The FDA product code for Fetal Doppler is KNG.

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