FDA 510(k)

Endure ETCO2/02 Nasal Cannula

K-번호: K213767 · 2023-09-12

결정일2023-09-12

제품 코드CCK

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

Endure ETCO2/02 Nasal Cannula is the device name listed in this FDA 510(k) record. The listed applicant is Endure Industries, Inc.. It received FDA 510(k) clearance on 2023-09-12 under 510(k) number K213767. The device is classified under product code CCK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Endure ETCO2/02 Nasal Cannula?

Endure ETCO2/02 Nasal Cannula is a medical device that received FDA 510(k) clearance on 2023-09-12. The listed applicant is Endure Industries, Inc.. The 510(k) number is K213767.

When did Endure ETCO2/02 Nasal Cannula receive FDA 510(k) clearance?

Endure ETCO2/02 Nasal Cannula received FDA 510(k) clearance on 2023-09-12, under 510(k) number K213767.

Who is the listed applicant for Endure ETCO2/02 Nasal Cannula?

The FDA 510(k) record lists Endure Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endure ETCO2/02 Nasal Cannula?

The FDA product code for Endure ETCO2/02 Nasal Cannula is CCK.

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Endure ETCO2/02 Nasal Cannula

기기 요약

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관련 임상시험

관련 기기 (코드: CCK)

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