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FDA 510(k)

AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM

K-Number: K896356 · 1990-08-21

ApplicantEsaote Biomedica Spa
Decision Date1990-08-21
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Esaote Biomedica Spa. It received FDA 510(k) clearance on 1990-08-21 under 510(k) number K896356. 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 AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM?

AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM is a medical device that received FDA 510(k) clearance on 1990-08-21. The listed applicant is Esaote Biomedica Spa. The 510(k) number is K896356.

When did AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM receive FDA 510(k) clearance?

AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM received FDA 510(k) clearance on 1990-08-21, under 510(k) number K896356.

Who is the listed applicant for AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM?

The FDA 510(k) record lists Esaote Biomedica Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM?

The FDA product code for AU530 DIAGNOSTIC ULTRASONIC PULSED ECHO SYSTEM is IYO.

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Other records listing Esaote Biomedica Spa as applicant

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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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