FDA 510(k)

再利用可能な温度プローブ、一次性温度プローブ

K番号: K223807 · 2023-08-25

申請者Shenzhen Sino-K Medical Technology Co.,Ltd

決定日2023-08-25

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

Reusable Temperature Probe, Disposable Temperature Probe is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-08-25 under 510(k) number K223807. 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 Reusable Temperature Probe, Disposable Temperature Probe?

Reusable Temperature Probe, Disposable Temperature Probe is a medical device that received FDA 510(k) clearance on 2023-08-25. The listed applicant is Shenzhen Sino-K Medical Technology Co.,Ltd. The 510(k) number is K223807.

When did Reusable Temperature Probe, Disposable Temperature Probe receive FDA 510(k) clearance?

Reusable Temperature Probe, Disposable Temperature Probe received FDA 510(k) clearance on 2023-08-25, under 510(k) number K223807.

Who is the listed applicant for Reusable Temperature Probe, Disposable Temperature Probe?

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

What is the FDA product code for Reusable Temperature Probe, Disposable Temperature Probe?

The FDA product code for Reusable Temperature Probe, Disposable Temperature Probe is FLL.

申請者としてShenzhen Sino-K Medical Technology Co.,Ltdを記載するその他の記録

K231961NIBPCuff K192608disposable SpO2センサー

公式ソース

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