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FDA 510(k)

TeleScan

K号: K220767 · 2022-04-14

申请人Bb Imaging
决定日期2022-04-14
产品代码LLZ
咨询委员会RA
决定实质等同

器械摘要

TeleScan is the device name listed in this FDA 510(k) record. The listed applicant is Bb Imaging. It received FDA 510(k) clearance on 2022-04-14 under 510(k) number K220767. 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 TeleScan?

TeleScan is a medical device that received FDA 510(k) clearance on 2022-04-14. The listed applicant is Bb Imaging. The 510(k) number is K220767.

When did TeleScan receive FDA 510(k) clearance?

TeleScan received FDA 510(k) clearance on 2022-04-14, under 510(k) number K220767.

Who is the listed applicant for TeleScan?

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

What is the FDA product code for TeleScan?

The FDA product code for TeleScan is LLZ.

相关临床试验

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列明Bb Imaging为申报人的其他记录

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相关器械(代码:LLZ)

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系;请查阅链接的官方来源。

官方来源

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