FDA 510(k)

Reflow系统迷你和ReFlow迷你冲洗器

K号: K223603 · 2022-12-29

决定日期2022-12-29

产品代码JXG

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决定实质等同

器械摘要

Reflow System Mini and ReFlow Mini Flusher is the device name listed in this FDA 510(k) record. The listed applicant is Anuncia Medical, Inc.. It received FDA 510(k) clearance on 2022-12-29 under 510(k) number K223603. The device is classified under product code JXG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Reflow System Mini and ReFlow Mini Flusher?

Reflow System Mini and ReFlow Mini Flusher is a medical device that received FDA 510(k) clearance on 2022-12-29. The listed applicant is Anuncia Medical, Inc.. The 510(k) number is K223603.

When did Reflow System Mini and ReFlow Mini Flusher receive FDA 510(k) clearance?

Reflow System Mini and ReFlow Mini Flusher received FDA 510(k) clearance on 2022-12-29, under 510(k) number K223603.

Who is the listed applicant for Reflow System Mini and ReFlow Mini Flusher?

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

What is the FDA product code for Reflow System Mini and ReFlow Mini Flusher?

The FDA product code for Reflow System Mini and ReFlow Mini Flusher is JXG.

列明Anuncia 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。

K221918ReFlow System Mini

相关器械（代码：JXG）

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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