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FDA 510(k)

Enovare Ultrasound System

K-Number: K153620 · 2016-05-05

ApplicantOreon Technologies, Inc.
Decision Date2016-05-05
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Enovare Ultrasound System is a medical device manufactured by Oreon Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-05 under approval number K153620. 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 Enovare Ultrasound System?

Enovare Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-05-05. It is manufactured by Oreon Technologies, Inc.. The 510(k) number is K153620.

When was Enovare Ultrasound System approved by the FDA?

Enovare Ultrasound System received FDA 510(k) clearance on 2016-05-05, under approval number K153620.

What company makes Enovare Ultrasound System?

Enovare Ultrasound System is manufactured by Oreon Technologies, Inc..

What is the FDA product code for Enovare Ultrasound System?

The FDA product code for Enovare Ultrasound System is 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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