FDA 510(k)

VaporMAX LDD；MOJo LDD；MegaJOULE LDD

K号: K233157 · 2024-05-03

决定日期2024-05-03

产品代码GEX

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决定实质等同

器械摘要

VaporMAX LDD; MOJo LDD; MegaJOULE LDD is the device name listed in this FDA 510(k) record. The listed applicant is Innovaquartz, LLC. It received FDA 510(k) clearance on 2024-05-03 under 510(k) number K233157. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the VaporMAX LDD; MOJo LDD; MegaJOULE LDD?

VaporMAX LDD; MOJo LDD; MegaJOULE LDD is a medical device that received FDA 510(k) clearance on 2024-05-03. The listed applicant is Innovaquartz, LLC. The 510(k) number is K233157.

When did VaporMAX LDD; MOJo LDD; MegaJOULE LDD receive FDA 510(k) clearance?

VaporMAX LDD; MOJo LDD; MegaJOULE LDD received FDA 510(k) clearance on 2024-05-03, under 510(k) number K233157.

Who is the listed applicant for VaporMAX LDD; MOJo LDD; MegaJOULE LDD?

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

What is the FDA product code for VaporMAX LDD; MOJo LDD; MegaJOULE LDD?

The FDA product code for VaporMAX LDD; MOJo LDD; MegaJOULE LDD is GEX. This falls under the Gastroenterology category.

列明Innovaquartz, LLC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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