FDA 510(k)

心律不齐通知功能（IRNF）

K号: K231173 · 2023-07-21

决定日期2023-07-21

产品代码QDB

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

Irregular Rhythm Notification Feature (IRNF) is the device name listed in this FDA 510(k) record. The listed applicant is Apple, Inc.. It received FDA 510(k) clearance on 2023-07-21 under 510(k) number K231173. The device is classified under product code QDB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Irregular Rhythm Notification Feature (IRNF)?

Irregular Rhythm Notification Feature (IRNF) is a medical device that received FDA 510(k) clearance on 2023-07-21. The listed applicant is Apple, Inc.. The 510(k) number is K231173.

When did Irregular Rhythm Notification Feature (IRNF) receive FDA 510(k) clearance?

Irregular Rhythm Notification Feature (IRNF) received FDA 510(k) clearance on 2023-07-21, under 510(k) number K231173.

Who is the listed applicant for Irregular Rhythm Notification Feature (IRNF)?

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

What is the FDA product code for Irregular Rhythm Notification Feature (IRNF)?

The FDA product code for Irregular Rhythm Notification Feature (IRNF) is QDB.

列明Apple, 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。

K253582医疗成像校准功能（MICF）K250507高血压通知功能（HTNF）K250143数字棱镜校正功能（DPCF）K242058数字棱镜校正功能（DPCF）K240929睡眠呼吸暂停通知功能（SANF）K213971房颤病史功能

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官方来源

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