FDA 510(k)

ENFit™ 커넥터를 사용한 확장 영양 공급 세트

K-번호: K250481 · 2025-04-18

결정일2025-04-18

제품 코드PIF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

Extension Feeding Set with ENFit™ Connectors is the device name listed in this FDA 510(k) record. The listed applicant is SKY Medical, a.s.. It received FDA 510(k) clearance on 2025-04-18 under 510(k) number K250481. The device is classified under product code PIF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Extension Feeding Set with ENFit™ Connectors?

Extension Feeding Set with ENFit™ Connectors is a medical device that received FDA 510(k) clearance on 2025-04-18. The listed applicant is SKY Medical, a.s.. The 510(k) number is K250481.

When did Extension Feeding Set with ENFit™ Connectors receive FDA 510(k) clearance?

Extension Feeding Set with ENFit™ Connectors received FDA 510(k) clearance on 2025-04-18, under 510(k) number K250481.

Who is the listed applicant for Extension Feeding Set with ENFit™ Connectors?

The FDA 510(k) record lists SKY Medical, a.s. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Extension Feeding Set with ENFit™ Connectors?

The FDA product code for Extension Feeding Set with ENFit™ Connectors is PIF.

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ENFit™ 커넥터를 사용한 확장 영양 공급 세트

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: PIF)

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