FDA 510(k)

赤外線体温計、モデル：PC808

K番号: K190717 · 2019-12-13

申請者Shenzhen Pacom Medical Instruments Co., Ltd.

決定日2019-12-13

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, model: PC808 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Pacom Medical Instruments Co., Ltd.. It received FDA 510(k) clearance on 2019-12-13 under 510(k) number K190717. 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, model: PC808?

Infrared Thermometer, model: PC808 is a medical device that received FDA 510(k) clearance on 2019-12-13. The listed applicant is Shenzhen Pacom Medical Instruments Co., Ltd.. The 510(k) number is K190717.

When did Infrared Thermometer, model: PC808 receive FDA 510(k) clearance?

Infrared Thermometer, model: PC808 received FDA 510(k) clearance on 2019-12-13, under 510(k) number K190717.

Who is the listed applicant for Infrared Thermometer, model: PC808?

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

What is the FDA product code for Infrared Thermometer, model: PC808?

The FDA product code for Infrared Thermometer, model: PC808 is FLL.

申請者としてShenzhen Pacom Medical Instruments Co., Ltd.を記載するその他の記録

K172889赤外線体温計

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