FDA 510(k)

VistaCam iX 证明

K号: K150672 · 2016-01-27

决定日期2016-01-27

产品代码NBL

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决定实质等同

器械摘要

VistaCam iX Proof is the device name listed in this FDA 510(k) record. The listed applicant is Durr Dental AG. It received FDA 510(k) clearance on 2016-01-27 under 510(k) number K150672. The device is classified under product code NBL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the VistaCam iX Proof?

VistaCam iX Proof is a medical device that received FDA 510(k) clearance on 2016-01-27. The listed applicant is Durr Dental AG. The 510(k) number is K150672.

When did VistaCam iX Proof receive FDA 510(k) clearance?

VistaCam iX Proof received FDA 510(k) clearance on 2016-01-27, under 510(k) number K150672.

Who is the listed applicant for VistaCam iX Proof?

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

What is the FDA product code for VistaCam iX Proof?

The FDA product code for VistaCam iX Proof is NBL.

列明Durr Dental AG为申报人的其他记录

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。

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官方来源

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