FDA 510(k)

ARTAIRA 动脉压迫装置 (AACD01)

K号: K240499 · 2024-10-11

决定日期2024-10-11

产品代码JOW

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

ARTAIRA Arterial Compression Device (AACD01) is the device name listed in this FDA 510(k) record. The listed applicant is Airos Medical, Inc.. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K240499. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ARTAIRA Arterial Compression Device (AACD01)?

ARTAIRA Arterial Compression Device (AACD01) is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Airos Medical, Inc.. The 510(k) number is K240499.

When did ARTAIRA Arterial Compression Device (AACD01) receive FDA 510(k) clearance?

ARTAIRA Arterial Compression Device (AACD01) received FDA 510(k) clearance on 2024-10-11, under 510(k) number K240499.

Who is the listed applicant for ARTAIRA Arterial Compression Device (AACD01)?

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

What is the FDA product code for ARTAIRA Arterial Compression Device (AACD01)?

The FDA product code for ARTAIRA Arterial Compression Device (AACD01) is JOW.

列明Airos 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。

K223193AIROS 8P 连续加压设备 K223195AIROS 6P 连续加压设备 K193069AIROS 6 连续加压设备 K193068AIROS 8 连续加压设备 K172779AIROS 8 连续加压设备 K172770AIROS 6 连续加压设备

查看所有 7 个设备 →

官方来源

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