FDA 510(k)

GlideScope BFlex 5.8 Single-Use Bronchoscope

K-번호: K191948 · 2019-08-21

결정일2019-08-21

제품 코드EOQ

자문 위원회EN

결정Substantially Equivalent

기기 요약

GlideScope BFlex 5.8 Single-Use Bronchoscope is the device name listed in this FDA 510(k) record. The listed applicant is Verathon Medical (Canada) Ulc. It received FDA 510(k) clearance on 2019-08-21 under 510(k) number K191948. The device is classified under product code EOQ. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the GlideScope BFlex 5.8 Single-Use Bronchoscope?

GlideScope BFlex 5.8 Single-Use Bronchoscope is a medical device that received FDA 510(k) clearance on 2019-08-21. The listed applicant is Verathon Medical (Canada) Ulc. The 510(k) number is K191948.

When did GlideScope BFlex 5.8 Single-Use Bronchoscope receive FDA 510(k) clearance?

GlideScope BFlex 5.8 Single-Use Bronchoscope received FDA 510(k) clearance on 2019-08-21, under 510(k) number K191948.

Who is the listed applicant for GlideScope BFlex 5.8 Single-Use Bronchoscope?

The FDA 510(k) record lists Verathon Medical (Canada) Ulc as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GlideScope BFlex 5.8 Single-Use Bronchoscope?

The FDA product code for GlideScope BFlex 5.8 Single-Use Bronchoscope is EOQ.

Verathon Medical (Canada) Ulc를 신청인으로 등재한 기타 기록

K253696CFlex Cystoscope - Standard Deflection (0570-0455); CFlex Cystoscope - Reverse Deflection (0570-0456); CystoView Monitor (0570-0465)K230948BFlex™ 2 Slim 3.8 Single-Use Bronchoscope K211947GlideScope BFlex 2.8 Single-Use Bronchoscope K193488GlideScope BFlex 3.8 Single-Use Bronchoscope K183256GlideScope BFlex Single-Use Bronchoscope System

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