FDA 510(k)

Quantum 加热器-冷却器

K号: K212657 · 2022-05-06

决定日期2022-05-06

产品代码DWC

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

Quantum Heater-Cooler is the device name listed in this FDA 510(k) record. The listed applicant is Spectrum Medical , Ltd.. It received FDA 510(k) clearance on 2022-05-06 under 510(k) number K212657. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Quantum Heater-Cooler?

Quantum Heater-Cooler is a medical device that received FDA 510(k) clearance on 2022-05-06. The listed applicant is Spectrum Medical , Ltd.. The 510(k) number is K212657.

When did Quantum Heater-Cooler receive FDA 510(k) clearance?

Quantum Heater-Cooler received FDA 510(k) clearance on 2022-05-06, under 510(k) number K212657.

Who is the listed applicant for Quantum Heater-Cooler?

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

What is the FDA product code for Quantum Heater-Cooler?

The FDA product code for Quantum Heater-Cooler is DWC.

列明Spectrum Medical , 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。

K240908Quantum 微型心肌保护输送系统；Quantum 微型心肌保护输送模块（QMCDM）K210669Quantum 微型通气模块 K202733Quantum 呼吸模块 K202557Quantum 工作站 12 Elite K192838Quantumn 中心血泵驱动-高压, Quantumn 中心血泵驱动-中压 K190282Quantum Smart Occluder LH (左手), Quantum Smart Occluder LH (右手)

查看所有 12 个设备 →

官方来源

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