FDA 510(k)

Vivid S60N, Vivid S70N

K番号: K170878 · 2017-06-14

申請者GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC

決定日2017-06-14

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

Vivid S60N, Vivid S70N is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2017-06-14 under 510(k) number K170878. 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 Vivid S60N, Vivid S70N?

Vivid S60N, Vivid S70N is a medical device that received FDA 510(k) clearance on 2017-06-14. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K170878.

When did Vivid S60N, Vivid S70N receive FDA 510(k) clearance?

Vivid S60N, Vivid S70N received FDA 510(k) clearance on 2017-06-14, under 510(k) number K170878.

Who is the listed applicant for Vivid S60N, Vivid S70N?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vivid S60N, Vivid S70N?

The FDA product code for Vivid S60N, Vivid S70N is IYN.

申請者としてGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCを記載するその他の記録

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公式ソース

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