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FDA 510(k)

CS-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

K-Number: K160921 · 2016-11-03

ApplicantCs Medical, LLC
Decision Date2016-11-03
Product CodePSW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CS-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 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 2016-11-03 under 510(k) number K160921. The device is classified under product code PSW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CS-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?

CS-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 is a medical device that received FDA 510(k) clearance on 2016-11-03. The listed applicant is Cs Medical, LLC. The 510(k) number is K160921.

When did CS-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 receive FDA 510(k) clearance?

CS-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 received FDA 510(k) clearance on 2016-11-03, under 510(k) number K160921.

Who is the listed applicant for CS-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?

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 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?

The FDA product code for CS-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 is PSW.

Other records listing Cs Medical, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorK230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical IndicatorK192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantK182891TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level Disinfectants

Related Devices (Code: PSW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233049TD 200® Automated TEE Probe Disinfector with TD-12® High-Level Disinfectant with QwikCheck™ Chemical IndicatorCs Medical, LLCK230381Ethos Automated Ultrasound Probe Cleaner Disinfector with AquaCide Cleaner/High-Level Disinfectant and QwikCheck Chemical IndicatorCs Medical, LLCK192228CS Medical TD 200 disinfector with TD-12 high-level disinfectant, CS Medical TD-12 high-level disinfectantCs Medical, LLCK182891TEEClean(R) Automated TEE Probe Cleaner Disinfector with TEEZyme(R) Cleaner and TD-5(R) or TD-8(R) High Level DisinfectantsCs Medical, LLC

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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