FDA 510(k)

ESI-3000 ULTRASOUND SYSTEM

K-Number: K904359 · 1991-03-05

Decision Date1991-03-05

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ESI-3000 ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1991-03-05 under 510(k) number K904359. 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 ESI-3000 ULTRASOUND SYSTEM?

ESI-3000 ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 1991-03-05. The listed applicant is Elscint, Inc.. The 510(k) number is K904359.

When did ESI-3000 ULTRASOUND SYSTEM receive FDA 510(k) clearance?

ESI-3000 ULTRASOUND SYSTEM received FDA 510(k) clearance on 1991-03-05, under 510(k) number K904359.

Who is the listed applicant for ESI-3000 ULTRASOUND SYSTEM?

The FDA 510(k) record lists Elscint, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESI-3000 ULTRASOUND SYSTEM?

The FDA product code for ESI-3000 ULTRASOUND SYSTEM 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.