FDA 510(k)

赤外線体温計モデル番号 RN-50A、RN-50B

K番号: K200578 · 2020-07-16

申請者Ningbo Ranor Medical Science & Technology Co., Ltd.

決定日2020-07-16

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 Number RN-50A,RN-50B is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Ranor Medical Science & Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-07-16 under 510(k) number K200578. 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 Number RN-50A,RN-50B?

Infrared Thermometer Model Number RN-50A,RN-50B is a medical device that received FDA 510(k) clearance on 2020-07-16. The listed applicant is Ningbo Ranor Medical Science & Technology Co., Ltd.. The 510(k) number is K200578.

When did Infrared Thermometer Model Number RN-50A,RN-50B receive FDA 510(k) clearance?

Infrared Thermometer Model Number RN-50A,RN-50B received FDA 510(k) clearance on 2020-07-16, under 510(k) number K200578.

Who is the listed applicant for Infrared Thermometer Model Number RN-50A,RN-50B?

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

What is the FDA product code for Infrared Thermometer Model Number RN-50A,RN-50B?

The FDA product code for Infrared Thermometer Model Number RN-50A,RN-50B is FLL.

申請者としてNingbo Ranor Medical Science & Technology Co., Ltd.を記載するその他の記録

K251143上腕血圧計（MJ1L、MJ2L、RN3L、RN4L、RN5L）K193456Arm Blood Pressure Monitor K200471赤外線体温計モデル番号 RN-60A、RN-60B

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