FDA 510(k)

6250 ULTRASOUND SYTEMS

K-Number: K103152 · 2011-01-07

Decision Date2011-01-07

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

6250 ULTRASOUND SYTEMS 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 2011-01-07 under 510(k) number K103152. 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 6250 ULTRASOUND SYTEMS?

6250 ULTRASOUND SYTEMS is a medical device that received FDA 510(k) clearance on 2011-01-07. The listed applicant is Esaote, S.p.A.. The 510(k) number is K103152.

When did 6250 ULTRASOUND SYTEMS receive FDA 510(k) clearance?

6250 ULTRASOUND SYTEMS received FDA 510(k) clearance on 2011-01-07, under 510(k) number K103152.

Who is the listed applicant for 6250 ULTRASOUND SYTEMS?

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 6250 ULTRASOUND SYTEMS?

The FDA product code for 6250 ULTRASOUND SYTEMS 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.