FDA 510(k)

赤外線体温計、モデル：YRK-002A、T8、T9、T10、T11

K番号: K203662 · 2021-09-23

申請者Yibin Junxin Electronics Technology Co., Ltd.

決定日2021-09-23

製品コードFLL

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 is the device name listed in this FDA 510(k) record. The listed applicant is Yibin Junxin Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K203662. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11?

Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is Yibin Junxin Electronics Technology Co., Ltd.. The 510(k) number is K203662.

When did Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 receive FDA 510(k) clearance?

Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 received FDA 510(k) clearance on 2021-09-23, under 510(k) number K203662.

Who is the listed applicant for Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11?

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

What is the FDA product code for Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11?

The FDA product code for Infrared thermometer, Models: YRK-002A, T8, T9, T10, T11 is FLL.

申請者としてYibin Junxin Electronics Technology Co., Ltd.を記載するその他の記録

K211532上腕血圧計、モデルOB30、OB31、OB32、OB33

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