FDA 510(k)

ACUSON S328 TRANSDUCER

K-Number: K874028 · 1988-06-21

Decision Date1988-06-21

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ACUSON S328 TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Computed Sonography. It received FDA 510(k) clearance on 1988-06-21 under 510(k) number K874028. 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 ACUSON S328 TRANSDUCER?

ACUSON S328 TRANSDUCER is a medical device that received FDA 510(k) clearance on 1988-06-21. The listed applicant is Acuson Computed Sonography. The 510(k) number is K874028.

When did ACUSON S328 TRANSDUCER receive FDA 510(k) clearance?

ACUSON S328 TRANSDUCER received FDA 510(k) clearance on 1988-06-21, under 510(k) number K874028.

Who is the listed applicant for ACUSON S328 TRANSDUCER?

The FDA 510(k) record lists Acuson Computed Sonography as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON S328 TRANSDUCER?

The FDA product code for ACUSON S328 TRANSDUCER is IYO.

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Other records listing Acuson Computed Sonography as applicant

K893863ACUSON L538 TRANSDUCER K874861ACUSON S328 TRANSDUCER FOR CARDIAC COLOR FLOW APP.K874363ACUSON S228 AND S328 TRANSDUCERS FOR ABDOM. APPLI.K874922ACUSON TRANSPERINEAL NEEDLE GUIDE K874860ACUSON I7505 TRANSDUCER FOR INTRACAVITARY APPLICA.K871506ACUSON L538 TRANSDUCER

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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.