FDA 510(k)

ULTRASOUND IMAGING SYSTEM, MODEL 7300

K-Number: K040596 · 2004-03-31

Decision Date2004-03-31

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ULTRASOUND IMAGING SYSTEM, MODEL 7300 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 2004-03-31 under 510(k) number K040596. 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 ULTRASOUND IMAGING SYSTEM, MODEL 7300?

ULTRASOUND IMAGING SYSTEM, MODEL 7300 is a medical device that received FDA 510(k) clearance on 2004-03-31. The listed applicant is Esaote, S.p.A.. The 510(k) number is K040596.

When did ULTRASOUND IMAGING SYSTEM, MODEL 7300 receive FDA 510(k) clearance?

ULTRASOUND IMAGING SYSTEM, MODEL 7300 received FDA 510(k) clearance on 2004-03-31, under 510(k) number K040596.

Who is the listed applicant for ULTRASOUND IMAGING SYSTEM, MODEL 7300?

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 ULTRASOUND IMAGING SYSTEM, MODEL 7300?

The FDA product code for ULTRASOUND IMAGING SYSTEM, MODEL 7300 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.