FDA 510(k)

BLU TOTALE (型号：ENEOB852)

K号: K232656 · 2023-11-14

决定日期2023-11-14

产品代码OLP

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决定实质等同

器械摘要

BLU TOTALE (Model: ENEOB852) is the device name listed in this FDA 510(k) record. The listed applicant is Premier North America, Inc.. It received FDA 510(k) clearance on 2023-11-14 under 510(k) number K232656. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the BLU TOTALE (Model: ENEOB852)?

BLU TOTALE (Model: ENEOB852) is a medical device that received FDA 510(k) clearance on 2023-11-14. The listed applicant is Premier North America, Inc.. The 510(k) number is K232656.

When did BLU TOTALE (Model: ENEOB852) receive FDA 510(k) clearance?

BLU TOTALE (Model: ENEOB852) received FDA 510(k) clearance on 2023-11-14, under 510(k) number K232656.

Who is the listed applicant for BLU TOTALE (Model: ENEOB852)?

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

What is the FDA product code for BLU TOTALE (Model: ENEOB852)?

The FDA product code for BLU TOTALE (Model: ENEOB852) is OLP.

列明Premier North America, 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。

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相关器械（代码：OLP）

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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