FDA 510(k)

Enovare Ultrasound System

K-Number: K153620 · 2016-05-05

Decision Date2016-05-05

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

Enovare Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is Oreon Technologies, Inc.. It received FDA 510(k) clearance on 2016-05-05 under 510(k) 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. The listed applicant is Oreon Technologies, Inc.. The 510(k) number is K153620.

When did Enovare Ultrasound System receive FDA 510(k) clearance?

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

Who is the listed applicant for Enovare Ultrasound System?

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

What is the FDA product code for Enovare Ultrasound System?

The FDA product code for Enovare Ultrasound System is IYO.

Related Devices (Code: IYO)

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Official Source

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