FDA 510(k)

AirStrip ONE网络客户端与警报通信管理（ACM）

K号: K211949 · 2021-12-09

决定日期2021-12-09

产品代码MSX

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

AirStrip ONE Web Client with Alarm Communication Management (ACM) is the device name listed in this FDA 510(k) record. The listed applicant is Airstrip Technologies, Inc.. It received FDA 510(k) clearance on 2021-12-09 under 510(k) number K211949. The device is classified under product code MSX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the AirStrip ONE Web Client with Alarm Communication Management (ACM)?

AirStrip ONE Web Client with Alarm Communication Management (ACM) is a medical device that received FDA 510(k) clearance on 2021-12-09. The listed applicant is Airstrip Technologies, Inc.. The 510(k) number is K211949.

When did AirStrip ONE Web Client with Alarm Communication Management (ACM) receive FDA 510(k) clearance?

AirStrip ONE Web Client with Alarm Communication Management (ACM) received FDA 510(k) clearance on 2021-12-09, under 510(k) number K211949.

Who is the listed applicant for AirStrip ONE Web Client with Alarm Communication Management (ACM)?

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

What is the FDA product code for AirStrip ONE Web Client with Alarm Communication Management (ACM)?

The FDA product code for AirStrip ONE Web Client with Alarm Communication Management (ACM) is MSX.

列明Airstrip Technologies, 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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