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FDA 510(k)

THE ESI-2000 ULTRASOUND UNIT

K-Number: K874683 · 1988-04-18

ApplicantElscint, Inc.
Decision Date1988-04-18
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

THE ESI-2000 ULTRASOUND UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Elscint, Inc.. It received FDA 510(k) clearance on 1988-04-18 under 510(k) number K874683. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE ESI-2000 ULTRASOUND UNIT?

THE ESI-2000 ULTRASOUND UNIT is a medical device that received FDA 510(k) clearance on 1988-04-18. The listed applicant is Elscint, Inc.. The 510(k) number is K874683.

When did THE ESI-2000 ULTRASOUND UNIT receive FDA 510(k) clearance?

THE ESI-2000 ULTRASOUND UNIT received FDA 510(k) clearance on 1988-04-18, under 510(k) number K874683.

Who is the listed applicant for THE ESI-2000 ULTRASOUND UNIT?

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 THE ESI-2000 ULTRASOUND UNIT?

The FDA product code for THE ESI-2000 ULTRASOUND UNIT is IYO.

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Related Devices (Code: IYO)

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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.

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