FDA 510(k)

CS Medical TD 200 소독기 및 TD-12 고급 소독제, CS Medical TD-12 고급 소독제

K-번호: K192228 · 2020-04-01

결정일2020-04-01

제품 코드PSW

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

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.

자주 묻는 질문

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.

Cs Medical, LLC를 신청인으로 등재한 기타 기록

K233049TD 200® 자동 TEE Probe 소독기 및 TD-12® 고급 소독제와 QwikCheck™ 화학 지표를 포함한 소독기 K230381에토스 자동 초음파探头 청소/소독기, 아쿠아사이드 청소제/고급 소독제와 퀵체크 화학 지표와 함께 K182891TEEClean(R) 자동 TEE Probe 청소 및 소독기, TEEZyme(R) 청소제 및 TD-5(R) 또는 TD-8(R) 고수준 소독제와 함께 K160921CS-메디칼 TD 100 소독기 및 TD-5, TD-8 고급 소독제, CS 메디칼 TD-5 고급 소독제, CS 메디칼 TD-8 고급 소독제

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