FDA 510(k)

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant

K号: K192228 · 2020-04-01

决定日期2020-04-01

产品代码PSW

咨询委员会RA

决定实质等同

器械摘要

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant is the device name listed in this FDA 510(k) record. The listed applicant is Cs Medical, LLC. It received FDA 510(k) clearance on 2020-04-01 under 510(k) number K192228. The device is classified under product code PSW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant?

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant is a medical device that received FDA 510(k) clearance on 2020-04-01. The listed applicant is Cs Medical, LLC. The 510(k) number is K192228.

When did CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant receive FDA 510(k) clearance?

CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant received FDA 510(k) clearance on 2020-04-01, under 510(k) number K192228.

Who is the listed applicant for CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant?

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

What is the FDA product code for CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant?

The FDA product code for CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectant is PSW.

列明Cs Medical, LLC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。

K233049TD 200® 自动化 TEE 探头消毒器，配备 TD-12® 高级消毒剂和 QwikCheck™ 化学指示剂 K230381Ethos 自动超声探头清洁消毒器，配备 AquaCide 清洁剂/高水平消毒剂和 QwikCheck 化学指示剂 K182891TEEClean(R) 自动化 TEE 探头清洁消毒器，配备 TEEZyme(R) 清洁剂和 TD-5(R) 或 TD-8(R) 高效消毒剂 K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level Disinfectant

相关器械（代码：PSW）

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。

K233049TD 200® 自动化 TEE 探头消毒器，配备 TD-12® 高级消毒剂和 QwikCheck™ 化学指示剂Cs Medical, LLC K230381Ethos 自动超声探头清洁消毒器，配备 AquaCide 清洁剂/高水平消毒剂和 QwikCheck 化学指示剂Cs Medical, LLC K182891TEEClean(R) 自动化 TEE 探头清洁消毒器，配备 TEEZyme(R) 清洁剂和 TD-5(R) 或 TD-8(R) 高效消毒剂Cs Medical, LLC K160921CS-Medical TD 100 Disinfector with TD-5 and TD-8 High Level Disinfectants, CS Medical TD-5 High Level Disinfectant, CS Medical TD-8 High Level DisinfectantCs Medical, LLC

官方来源

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