FDA 510(k)

Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo

K号: K240298 · 2024-08-21

决定日期2024-08-21

产品代码FRO

决定实质等同

器械摘要

Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo is the device name listed in this FDA 510(k) record. The listed applicant is Bionova Medical, Inc.. It received FDA 510(k) clearance on 2024-08-21 under 510(k) number K240298. The device is classified under product code FRO. Product code FRO falls under the category of Anesthesiology, which includes devices for anesthetic delivery and patient monitoring. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常见问题

What is the Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo?

Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo is a medical device that received FDA 510(k) clearance on 2024-08-21. The listed applicant is Bionova Medical, Inc.. The 510(k) number is K240298.

When did Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo receive FDA 510(k) clearance?

Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo received FDA 510(k) clearance on 2024-08-21, under 510(k) number K240298.

Who is the listed applicant for Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo?

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

What is the FDA product code for Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo?

The FDA product code for Foundation Dermal Regeneration Scaffold Plus (DRS+) Duo is FRO. This falls under the Anesthesiology category.

列明Bionova 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。

K243181Foundation Dermal Regeneration Scaffold Plus (DRS+) Solo K231937Foundation Dermal Regeneration Scaffold (DRS) Solo K210949Foundation Dermal Regeneration Scaffold (DRS) Solo

官方来源

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