FDA 510(k)

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)

K-번호: K163412 · 2017-06-22

결정일2017-06-22

제품 코드CCW

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

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is the device name listed in this FDA 510(k) record. The listed applicant is Girgis Scope, LLC. It received FDA 510(k) clearance on 2017-06-22 under 510(k) number K163412. The device is classified under product code CCW. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is a medical device that received FDA 510(k) clearance on 2017-06-22. The listed applicant is Girgis Scope, LLC. The 510(k) number is K163412.

When did Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) receive FDA 510(k) clearance?

Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) received FDA 510(k) clearance on 2017-06-22, under 510(k) number K163412.

Who is the listed applicant for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

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

What is the FDA product code for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)?

The FDA product code for Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL) is CCW.

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Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: CCW)

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