FDA 510(k)

Biobeat平台-2和BB-613WP贴片

K号: K222010 · 2022-12-30

决定日期2022-12-30

产品代码DQA

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

Biobeat Platform-2 and BB-613WP Patch is the device name listed in this FDA 510(k) record. The listed applicant is Biobeat Technologies , Ltd.. It received FDA 510(k) clearance on 2022-12-30 under 510(k) number K222010. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Biobeat Platform-2 and BB-613WP Patch?

Biobeat Platform-2 and BB-613WP Patch is a medical device that received FDA 510(k) clearance on 2022-12-30. The listed applicant is Biobeat Technologies , Ltd.. The 510(k) number is K222010.

When did Biobeat Platform-2 and BB-613WP Patch receive FDA 510(k) clearance?

Biobeat Platform-2 and BB-613WP Patch received FDA 510(k) clearance on 2022-12-30, under 510(k) number K222010.

Who is the listed applicant for Biobeat Platform-2 and BB-613WP Patch?

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

What is the FDA product code for Biobeat Platform-2 and BB-613WP Patch?

The FDA product code for Biobeat Platform-2 and BB-613WP Patch is DQA.

列明Biobeat Technologies , Ltd.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。

K241066BB-613-BPM K212153Biobeat平台，BB-613WP贴片 K190792BB-613WP

相关器械（代码：DQA）

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。

K252821可重复使用成人SpO2夹式传感器（3m）（M1196A）；可重复使用成人SpO2夹式传感器（0.9m）（M1196T）Philips Medizin Systeme Böblingen GmbH K252655脉搏血氧仪（PO-A2AO，PO-A2AT，PO-A3AO，PO-H1AO，PO-B1AO，PO-C5AO，PO-C5AT，PO-C6AO， PO-C6AT）Shenzhen Imdk Medical Technology Co., Ltd.K253887鼻翼SpO2传感器（989803205381）；鼻翼SpO2传感器（989803205391）；鼻翼Sp02传感器（989803205401）Philips Medizin Systeme K260931Unimed可重复使用指夹式SpO2传感器（U403-49R和U103-49R）Unimed Medical Supplies, Inc.K252448AViTA 脉搏血氧仪 (SP61)Avita Corporation K252805优威尔®指夹式脉搏血氧仪（YX105，YX106，YX110，YX310）Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.

官方来源

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