FDA 510(k)

胎児ドプラー U8-25、U9-25

K番号: K252669 · 2026-01-08

申請者Zhongshan Xiaolan Town Senlan Electronic Factory

決定日2026-01-08

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 U8-25, U9-25 is the device name listed in this FDA 510(k) record. The listed applicant is Zhongshan Xiaolan Town Senlan Electronic Factory. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K252669. 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 U8-25, U9-25?

Fetal Doppler U8-25, U9-25 is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is Zhongshan Xiaolan Town Senlan Electronic Factory. The 510(k) number is K252669.

When did Fetal Doppler U8-25, U9-25 receive FDA 510(k) clearance?

Fetal Doppler U8-25, U9-25 received FDA 510(k) clearance on 2026-01-08, under 510(k) number K252669.

Who is the listed applicant for Fetal Doppler U8-25, U9-25?

The FDA 510(k) record lists Zhongshan Xiaolan Town Senlan Electronic Factory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Fetal Doppler U8-25, U9-25?

The FDA product code for Fetal Doppler U8-25, U9-25 is KNG.

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胎児ドプラー U8-25、U9-25

医療機器の概要

よくある質問

関連する臨床試験

関連機器（コード：KNG）

公式ソース