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 the device name listed in this FDA 510(k) record. The listed applicant is Navigant Consulting - on Behalf of Esaote S.P.A.. It received FDA 510(k) clearance on 2019-04-01 under 510(k) 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. The listed applicant is Navigant Consulting - on Behalf of Esaote S.P.A.. The 510(k) number is K190447.

When did 7400 Ultrasound Systems receive FDA 510(k) clearance?

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

Who is the listed applicant for 7400 Ultrasound Systems?

The FDA 510(k) record lists Navigant Consulting - on Behalf of Esaote S.P.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7400 Ultrasound Systems?

The FDA product code for 7400 Ultrasound Systems is IYN.

Related Devices (Code: IYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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