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FDA 510(k)

Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound

K-Number: K160792 · 2016-04-15

ApplicantThe Prometheus Group
Decision Date2016-04-15
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

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. It is manufactured by The Prometheus Group. The 510(k) number is K160792.

When was Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound approved by the FDA?

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

What company makes Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound?

Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder Ultrasound is manufactured by The Prometheus Group.

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.

Related Clinical Trials

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Related Devices (Code: IYO)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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