FDA 510(k)

7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350

K-Number: K050326 · 2005-02-28

Decision Date2005-02-28

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote, S.p.A.. It received FDA 510(k) clearance on 2005-02-28 under 510(k) number K050326. 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 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350?

7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 is a medical device that received FDA 510(k) clearance on 2005-02-28. The listed applicant is Esaote, S.p.A.. The 510(k) number is K050326.

When did 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 receive FDA 510(k) clearance?

7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 received FDA 510(k) clearance on 2005-02-28, under 510(k) number K050326.

Who is the listed applicant for 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350?

The FDA 510(k) record lists Esaote, S.p.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350?

The FDA product code for 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 is 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.