FDA 510(k)

FMX314 수술 플랫폼

K-번호: K160797 · 2016-08-26

결정일2016-08-26

제품 코드OTJ

자문 위원회규제 정책: medical-regulatory-v1 GU

결정Substantially Equivalent

기기 요약

FMX314 Surgical Platform is the device name listed in this FDA 510(k) record. The listed applicant is Fortimedix Surgical B.V.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K160797. The device is classified under product code OTJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the FMX314 Surgical Platform?

FMX314 Surgical Platform is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Fortimedix Surgical B.V.. The 510(k) number is K160797.

When did FMX314 Surgical Platform receive FDA 510(k) clearance?

FMX314 Surgical Platform received FDA 510(k) clearance on 2016-08-26, under 510(k) number K160797.

Who is the listed applicant for FMX314 Surgical Platform?

The FDA 510(k) record lists Fortimedix Surgical B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FMX314 Surgical Platform?

The FDA product code for FMX314 Surgical Platform is OTJ.

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FMX314 수술 플랫폼

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: OTJ)

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