FDA 510(k)

スマートアス EXT-1M/3M

K番号: K163121 · 2017-08-10

決定日2017-08-10

製品コードIYN

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

SmartUs EXT-1M/3M is the device name listed in this FDA 510(k) record. The listed applicant is Telemed. It received FDA 510(k) clearance on 2017-08-10 under 510(k) number K163121. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the SmartUs EXT-1M/3M?

SmartUs EXT-1M/3M is a medical device that received FDA 510(k) clearance on 2017-08-10. The listed applicant is Telemed. The 510(k) number is K163121.

When did SmartUs EXT-1M/3M receive FDA 510(k) clearance?

SmartUs EXT-1M/3M received FDA 510(k) clearance on 2017-08-10, under 510(k) number K163121.

Who is the listed applicant for SmartUs EXT-1M/3M?

The FDA 510(k) record lists Telemed as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SmartUs EXT-1M/3M?

The FDA product code for SmartUs EXT-1M/3M is IYN.

申請者としてTelemedを記載するその他の記録

K211248ArtUs K161968マイクロス

関連機器（コード：IYN）

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