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FDA 510(k)

查看此医疗设备监管文本: View the medical-device regulatory text for this device_name.

K号: K253639 · 2026-01-08

申请人GE Healthcare
决定日期2026-01-08
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

View is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2026-01-08 under 510(k) number K253639. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the View?

View is a medical device that received FDA 510(k) clearance on 2026-01-08. The listed applicant is GE Healthcare. The 510(k) number is K253639.

When did View receive FDA 510(k) clearance?

View received FDA 510(k) clearance on 2026-01-08, under 510(k) number K253639.

Who is the listed applicant for View?

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

What is the FDA product code for View?

The FDA product code for View is LLZ.

相关 PubMed 文献

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列明GE Healthcare为申报人的其他记录

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查看所有 55 个设备 →

相关器械(代码:LLZ)

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官方来源

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