FDA 510(k)

모페러스 레얼타임 초음파, 패스웨이 레얼타임 초음파, 퀵스캔 블랜더 초음파

K-번호: K160792 · 2016-04-15

결정일2016-04-15

제품 코드IYO

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound is the device name listed in this FDA 510(k) record. The listed applicant is The Prometheus Group. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K160792. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound?

Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is The Prometheus Group. The 510(k) number is K160792.

When did Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound receive FDA 510(k) clearance?

Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound received FDA 510(k) clearance on 2016-04-15, under 510(k) number K160792.

Who is the listed applicant for Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound?

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

What is the FDA product code for Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound?

The FDA product code for Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound is IYO.

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모페러스 레얼타임 초음파, 패스웨이 레얼타임 초음파, 퀵스캔 블랜더 초음파

기기 요약

자주 묻는 질문

관련 임상시험

관련 기기 (코드: IYO)

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