FDA 510(k)

Cardiart 电子听诊器型号 DS101 Omni-Steth 电子听诊器型号 Omni-Steth

K号: K182196 · 2018-09-11

决定日期2018-09-11

产品代码DQD

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

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is the device name listed in this FDA 510(k) record. The listed applicant is Imediplus, Inc.. It received FDA 510(k) clearance on 2018-09-11 under 510(k) number K182196. The device is classified under product code DQD. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is a medical device that received FDA 510(k) clearance on 2018-09-11. The listed applicant is Imediplus, Inc.. The 510(k) number is K182196.

When did Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth receive FDA 510(k) clearance?

Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth received FDA 510(k) clearance on 2018-09-11, under 510(k) number K182196.

Who is the listed applicant for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

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

What is the FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth?

The FDA product code for Cardiart Electronic Stethoscope Model DS101 Omni-Steth Electronic Stethoscope Model Omni-Steth is DQD.

列明Imediplus, 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。

K173663电子听诊器DS3011A K160023电子听诊器DS301

官方来源

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