FDA 510(k)

GUS831 컴프레서 분말기

K-번호: K192633 · 2020-05-01

신청자Globalcare Medical Technology Co., Ltd.

결정일2020-05-01

제품 코드CAF

자문 위원회안내: 의료기기 규제 문서 번역 요청입니다. 회사명, 제품명, FDA, 510(k), PMA, NCT, PMID, 식별자 및 URL을 보존하여 번역하여 주세요. 정책: 의료규제-v1. [원문] AN [번역] 안내

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기기 요약

GUS831 Compressor Nebulizer is the device name listed in this FDA 510(k) record. The listed applicant is Globalcare Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-05-01 under 510(k) number K192633. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the GUS831 Compressor Nebulizer?

GUS831 Compressor Nebulizer is a medical device that received FDA 510(k) clearance on 2020-05-01. The listed applicant is Globalcare Medical Technology Co., Ltd.. The 510(k) number is K192633.

When did GUS831 Compressor Nebulizer receive FDA 510(k) clearance?

GUS831 Compressor Nebulizer received FDA 510(k) clearance on 2020-05-01, under 510(k) number K192633.

Who is the listed applicant for GUS831 Compressor Nebulizer?

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

What is the FDA product code for GUS831 Compressor Nebulizer?

The FDA product code for GUS831 Compressor Nebulizer is CAF.

Globalcare Medical Technology Co., Ltd.를 신청인으로 등재한 기타 기록

K253896TENS/EMS 장치 (GUSE01)K250136글로벌케어 혈압 모니터 (GUS610)K222160GUS610 혈압 모니터 K192609글로벌케어 혈압 모니터

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