FDA 510(k)

Monaghan medical filtered mouthpiece kit

K-번호: K220145 · 2023-08-24

결정일2023-08-24

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

결정Substantially Equivalent

기기 요약

Monaghan medical filtered mouthpiece kit is the device name listed in this FDA 510(k) record. The listed applicant is Monaghan Medical Corporation. It received FDA 510(k) clearance on 2023-08-24 under 510(k) number K220145. 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 Monaghan medical filtered mouthpiece kit?

Monaghan medical filtered mouthpiece kit is a medical device that received FDA 510(k) clearance on 2023-08-24. The listed applicant is Monaghan Medical Corporation. The 510(k) number is K220145.

When did Monaghan medical filtered mouthpiece kit receive FDA 510(k) clearance?

Monaghan medical filtered mouthpiece kit received FDA 510(k) clearance on 2023-08-24, under 510(k) number K220145.

Who is the listed applicant for Monaghan medical filtered mouthpiece kit?

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

What is the FDA product code for Monaghan medical filtered mouthpiece kit?

The FDA product code for Monaghan medical filtered mouthpiece kit is CAF.

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Monaghan medical filtered mouthpiece kit

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: CAF)

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