FDA 510(k)

Coala 心脏监测仪

K号: K212163 · 2022-04-14

决定日期2022-04-14

产品代码DPS

咨询委员会CV 请注意，由于原文未提供具体内容，以下是一个示例翻译： --- 产品名称：[产品名称] 公司名称：[公司名称] FDA批准号：[FDA批准号] 510(k)申请号：[510(k)申请号] PMA申请号：[PMA申请号] 临床试验注册号：[NCT] PubMed ID：[PMID] 产品标识符：[标识符] 产品URL：[URL] --- 请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。

决定实质等同

器械摘要

Coala Heart Monitor is the device name listed in this FDA 510(k) record. The listed applicant is Coala Life AB. It received FDA 510(k) clearance on 2022-04-14 under 510(k) number K212163. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Coala Heart Monitor?

Coala Heart Monitor is a medical device that received FDA 510(k) clearance on 2022-04-14. The listed applicant is Coala Life AB. The 510(k) number is K212163.

When did Coala Heart Monitor receive FDA 510(k) clearance?

Coala Heart Monitor received FDA 510(k) clearance on 2022-04-14, under 510(k) number K212163.

Who is the listed applicant for Coala Heart Monitor?

The FDA 510(k) record lists Coala Life AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Coala Heart Monitor?

The FDA product code for Coala Heart Monitor is DPS.

列明Coala Life AB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。

K182040Coala 心脏监测仪

官方来源

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