Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Eye Prime

K-Number: K190786 · 2019-04-11

ApplicantEllex Medical Pty, Ltd.
Decision Date2019-04-11
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Eye Prime is a medical device manufactured by Ellex Medical Pty, Ltd.. It received FDA 510(k) clearance on 2019-04-11 under approval number K190786. 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 Eye Prime?

Eye Prime is a medical device that received FDA 510(k) clearance on 2019-04-11. It is manufactured by Ellex Medical Pty, Ltd.. The 510(k) number is K190786.

When was Eye Prime approved by the FDA?

Eye Prime received FDA 510(k) clearance on 2019-04-11, under approval number K190786.

What company makes Eye Prime?

Eye Prime is manufactured by Ellex Medical Pty, Ltd..

What is the FDA product code for Eye Prime?

The FDA product code for Eye Prime is IYO.

Other Devices by Ellex Medical Pty, Ltd.

K212630Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo K222395Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo

Related Devices (Code: IYO)

K162972ExactVu High Resolution Micro-Ultrasound SystemExact Imaging K161968MicrUsTelemed K161342Sonic WindowAnalogic Corporation K161300Acclarix AX8 Diagnostic Ultrasound SystemEdan Instruments, Inc. K153620Enovare Ultrasound SystemOreon Technologies, Inc. K160792Morpheus RealTime Ultrasound, Pathway RealTime Ultrasound, QuickScan Bladder UltrasoundThe Prometheus Group

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.

↑