FDA 510(k)

SOMAVAC® 100 持续真空系统

K号: K231063 · 2023-05-12

决定日期2023-05-12

产品代码BTA

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决定实质等同

器械摘要

SOMAVAC® 100 Sustained Vacuum System is the device name listed in this FDA 510(k) record. The listed applicant is Somavac Medical Solutions, Inc.. It received FDA 510(k) clearance on 2023-05-12 under 510(k) number K231063. The device is classified under product code BTA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the SOMAVAC® 100 Sustained Vacuum System?

SOMAVAC® 100 Sustained Vacuum System is a medical device that received FDA 510(k) clearance on 2023-05-12. The listed applicant is Somavac Medical Solutions, Inc.. The 510(k) number is K231063.

When did SOMAVAC® 100 Sustained Vacuum System receive FDA 510(k) clearance?

SOMAVAC® 100 Sustained Vacuum System received FDA 510(k) clearance on 2023-05-12, under 510(k) number K231063.

Who is the listed applicant for SOMAVAC® 100 Sustained Vacuum System?

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

What is the FDA product code for SOMAVAC® 100 Sustained Vacuum System?

The FDA product code for SOMAVAC® 100 Sustained Vacuum System is BTA.

列明Somavac Medical Solutions, 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。

K222856SOMAVAC 100 Sustained Vacuum System K180606SOMAVAC Device

相关器械（代码：BTA）

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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