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FDA 510(k)

SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4

K-Number: K890963 · 1989-07-19

ApplicantEsaote Biomedica Elettronica
Decision Date1989-07-19
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 is the device name listed in this FDA 510(k) record. The listed applicant is Esaote Biomedica Elettronica. It received FDA 510(k) clearance on 1989-07-19 under 510(k) number K890963. 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 SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4?

SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 is a medical device that received FDA 510(k) clearance on 1989-07-19. The listed applicant is Esaote Biomedica Elettronica. The 510(k) number is K890963.

When did SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 receive FDA 510(k) clearance?

SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 received FDA 510(k) clearance on 1989-07-19, under 510(k) number K890963.

Who is the listed applicant for SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4?

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

What is the FDA product code for SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4?

The FDA product code for SIM 4000I ULTRASOUND SYSTEM-TRANSDUCER FOR SM 24/4 is 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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