FDA 510(k)

네vap 아시어 Subglottic 수술 내트레이스 튜브 (ASSET) 및 프리로드 스타일렛

K-번호: K172208 · 2018-02-16

결정일2018-02-16

제품 코드BTR

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

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기기 요약

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is the device name listed in this FDA 510(k) record. The listed applicant is Nevap, Inc.. It received FDA 510(k) clearance on 2018-02-16 under 510(k) number K172208. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is a medical device that received FDA 510(k) clearance on 2018-02-16. The listed applicant is Nevap, Inc.. The 510(k) number is K172208.

When did NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet receive FDA 510(k) clearance?

NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet received FDA 510(k) clearance on 2018-02-16, under 510(k) number K172208.

Who is the listed applicant for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

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

What is the FDA product code for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet?

The FDA product code for NeVap Aspire Subglottic Suction Endotracheal Tube (ASSET) with Preloaded Stylet is BTR.

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네vap 아시어 Subglottic 수술 내트레이스 튜브 (ASSET) 및 프리로드 스타일렛

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: BTR)

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