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FDA 510(k)

7400 Ultrasound Systems

K-Number: K190447 · 2019-04-01

ApplicantNavigant Consulting - on Behalf of Esaote S.P.A.
Decision Date2019-04-01
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

7400 Ultrasound Systems is a medical device manufactured by Navigant Consulting - on Behalf of Esaote S.P.A.. It received FDA 510(k) clearance on 2019-04-01 under approval number K190447. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 7400 Ultrasound Systems?

7400 Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2019-04-01. It is manufactured by Navigant Consulting - on Behalf of Esaote S.P.A.. The 510(k) number is K190447.

When was 7400 Ultrasound Systems approved by the FDA?

7400 Ultrasound Systems received FDA 510(k) clearance on 2019-04-01, under approval number K190447.

What company makes 7400 Ultrasound Systems?

7400 Ultrasound Systems is manufactured by Navigant Consulting - on Behalf of Esaote S.P.A..

What is the FDA product code for 7400 Ultrasound Systems?

The FDA product code for 7400 Ultrasound Systems is IYN.

Related Clinical Trials

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Related Devices (Code: IYN)

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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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