FDA 510(k)

Ancora-SB

K号: K231323 · 2023-08-31

决定日期2023-08-31

产品代码FDA

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决定实质等同

器械摘要

Ancora-SB is the device name listed in this FDA 510(k) record. The listed applicant is Aspero Medical, Inc.. It received FDA 510(k) clearance on 2023-08-31 under 510(k) number K231323. The device is classified under product code FDA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Ancora-SB?

Ancora-SB is a medical device that received FDA 510(k) clearance on 2023-08-31. The listed applicant is Aspero Medical, Inc.. The 510(k) number is K231323.

When did Ancora-SB receive FDA 510(k) clearance?

Ancora-SB received FDA 510(k) clearance on 2023-08-31, under 510(k) number K231323.

Who is the listed applicant for Ancora-SB?

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

What is the FDA product code for Ancora-SB?

The FDA product code for Ancora-SB is FDA.

列明Aspero Medical, Inc.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。

K260314Ancora-SB

官方来源

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