FDA 510(k)

Schoelly Cystoscopes/Hysteroscopes and Accessories

K-번호: K201970 · 2020-10-08

결정일2020-10-08

제품 코드HIH

자문 위원회OB

결정Substantially Equivalent

기기 요약

Schoelly Cystoscopes/Hysteroscopes and Accessories is the device name listed in this FDA 510(k) record. The listed applicant is Schoelly Fiberoptic GmbH. It received FDA 510(k) clearance on 2020-10-08 under 510(k) number K201970. The device is classified under product code HIH. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Schoelly Cystoscopes/Hysteroscopes and Accessories?

Schoelly Cystoscopes/Hysteroscopes and Accessories is a medical device that received FDA 510(k) clearance on 2020-10-08. The listed applicant is Schoelly Fiberoptic GmbH. The 510(k) number is K201970.

When did Schoelly Cystoscopes/Hysteroscopes and Accessories receive FDA 510(k) clearance?

Schoelly Cystoscopes/Hysteroscopes and Accessories received FDA 510(k) clearance on 2020-10-08, under 510(k) number K201970.

Who is the listed applicant for Schoelly Cystoscopes/Hysteroscopes and Accessories?

The FDA 510(k) record lists Schoelly Fiberoptic GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Schoelly Cystoscopes/Hysteroscopes and Accessories?

The FDA product code for Schoelly Cystoscopes/Hysteroscopes and Accessories is HIH.

Schoelly Fiberoptic GmbH를 신청인으로 등재한 기타 기록

K233225SCHOELLY Oxygen Saturation Imaging (OSI) Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope)K221591Camera System (Camera Control Unit, Camera Head to be coupled to a fiberoptic scope), NIR FI Light Source K201617TipVision Videoscope System (TipVision VideoScope 0°/30°; EleVision HD 2 Camera Control Unit (CCU))K151308Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set

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