FDA 510(k)

OPTIS Metallic Stent Optimization E.4 SW

K-번호: K160878 · 2016-06-29

결정일2016-06-29

제품 코드NQQ

자문 위원회RA

결정Substantially Equivalent

기기 요약

OPTIS Metallic Stent Optimization E.4 SW is the device name listed in this FDA 510(k) record. The listed applicant is Lightlab Imaging, Inc.. It received FDA 510(k) clearance on 2016-06-29 under 510(k) number K160878. The device is classified under product code NQQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the OPTIS Metallic Stent Optimization E.4 SW?

OPTIS Metallic Stent Optimization E.4 SW is a medical device that received FDA 510(k) clearance on 2016-06-29. The listed applicant is Lightlab Imaging, Inc.. The 510(k) number is K160878.

When did OPTIS Metallic Stent Optimization E.4 SW receive FDA 510(k) clearance?

OPTIS Metallic Stent Optimization E.4 SW received FDA 510(k) clearance on 2016-06-29, under 510(k) number K160878.

Who is the listed applicant for OPTIS Metallic Stent Optimization E.4 SW?

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

What is the FDA product code for OPTIS Metallic Stent Optimization E.4 SW?

The FDA product code for OPTIS Metallic Stent Optimization E.4 SW is NQQ.

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OPTIS Metallic Stent Optimization E.4 SW

기기 요약

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관련 임상시험

관련 기기 (코드: NQQ)

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