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FDA 510(k)

Clench Relief 口腔件 PRO RX, Clench Relief 口腔件

K号: K222845 · 2023-11-28

决定日期2023-11-28
产品代码MQC
决定实质等同

器械摘要

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is the device name listed in this FDA 510(k) record. The listed applicant is Frey Oral Technologies, LLC. It received FDA 510(k) clearance on 2023-11-28 under 510(k) number K222845. The device is classified under product code MQC. FDA Decision: Substantially Equivalent.

常见问题

What is the Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is a medical device that received FDA 510(k) clearance on 2023-11-28. The listed applicant is Frey Oral Technologies, LLC. The 510(k) number is K222845.

When did Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece receive FDA 510(k) clearance?

Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece received FDA 510(k) clearance on 2023-11-28, under 510(k) number K222845.

Who is the listed applicant for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

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

What is the FDA product code for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece?

The FDA product code for Clench Relief Mouth Piece PRO RX, Clench Relief Mouth Piece is MQC.

相关临床试验

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。

相关器械(代码:MQC)

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。

官方来源

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