FDA 510(k)

Dermal Cooling System

K号: K213294 · 2022-11-10

决定日期2022-11-10

产品代码QPZ

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决定实质等同

器械摘要

Dermal Cooling System is the device name listed in this FDA 510(k) record. The listed applicant is R2 Technologies, Inc.. It received FDA 510(k) clearance on 2022-11-10 under 510(k) number K213294. The device is classified under product code QPZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Dermal Cooling System?

Dermal Cooling System is a medical device that received FDA 510(k) clearance on 2022-11-10. The listed applicant is R2 Technologies, Inc.. The 510(k) number is K213294.

When did Dermal Cooling System receive FDA 510(k) clearance?

Dermal Cooling System received FDA 510(k) clearance on 2022-11-10, under 510(k) number K213294.

Who is the listed applicant for Dermal Cooling System?

The FDA 510(k) record lists R2 Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dermal Cooling System?

The FDA product code for Dermal Cooling System is QPZ.

列明R2 Technologies, 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。

K203006R2 皮肤磨削头（用于皮肤冷却系统）K201260Dermal Cooling System

官方来源

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