FDA 510(k)

에어 캡터 Plus* 플로우-뷰* 방전 방지 밸브형 유지 캡스터 (VHC)

K-번호: K181649 · 2019-01-11

결정일2019-01-11

제품 코드NVP

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

결정대체적으로 동일

기기 요약

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is the device name listed in this FDA 510(k) record. The listed applicant is Trudell Medical International. It received FDA 510(k) clearance on 2019-01-11 under 510(k) number K181649. The device is classified under product code NVP. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)?

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is a medical device that received FDA 510(k) clearance on 2019-01-11. The listed applicant is Trudell Medical International. The 510(k) number is K181649.

When did AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) receive FDA 510(k) clearance?

AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) received FDA 510(k) clearance on 2019-01-11, under 510(k) number K181649.

Who is the listed applicant for AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)?

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

What is the FDA product code for AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)?

The FDA product code for AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC) is NVP.

Trudell Medical International를 신청인으로 등재한 기타 기록

K242667에어 캡터2고 방전 방지 밸브형 유지 캡스터 K203400부상된 튜브와 머리piec 액세서리 K200063AeroEclipse* ONE 벤 K183108결합된 Aerobika OPEP 및 VersaPAP 장치 K173918VersaPAP Positive Airway Pressure (PAP) Device K173825MC 300R* 인haler

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