FDA 510(k)

REGER 압력 Nebulizer 이식 캘루라

K-번호: K231622 · 2023-09-29

결정일2023-09-29

제품 코드GCJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

REGER Nebulizer Irrigation Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Reger Medizintechnik, GmbH. It received FDA 510(k) clearance on 2023-09-29 under 510(k) number K231622. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the REGER Nebulizer Irrigation Cannula?

REGER Nebulizer Irrigation Cannula is a medical device that received FDA 510(k) clearance on 2023-09-29. The listed applicant is Reger Medizintechnik, GmbH. The 510(k) number is K231622.

When did REGER Nebulizer Irrigation Cannula receive FDA 510(k) clearance?

REGER Nebulizer Irrigation Cannula received FDA 510(k) clearance on 2023-09-29, under 510(k) number K231622.

Who is the listed applicant for REGER Nebulizer Irrigation Cannula?

The FDA 510(k) record lists Reger Medizintechnik, GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REGER Nebulizer Irrigation Cannula?

The FDA product code for REGER Nebulizer Irrigation Cannula is GCJ.

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REGER 압력 Nebulizer 이식 캘루라

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: GCJ)

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