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FDA 510(k)

ACUSON I5100 ULTRASOUND TRANSDUCER

K-Number: K884632 · 1989-01-13

ApplicantAcuson Corp.
Decision Date1989-01-13
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ACUSON I5100 ULTRASOUND TRANSDUCER is the device name listed in this FDA 510(k) record. The listed applicant is Acuson Corp.. It received FDA 510(k) clearance on 1989-01-13 under 510(k) number K884632. 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 I5100 ULTRASOUND TRANSDUCER?

ACUSON I5100 ULTRASOUND TRANSDUCER is a medical device that received FDA 510(k) clearance on 1989-01-13. The listed applicant is Acuson Corp.. The 510(k) number is K884632.

When did ACUSON I5100 ULTRASOUND TRANSDUCER receive FDA 510(k) clearance?

ACUSON I5100 ULTRASOUND TRANSDUCER received FDA 510(k) clearance on 1989-01-13, under 510(k) number K884632.

Who is the listed applicant for ACUSON I5100 ULTRASOUND TRANSDUCER?

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

What is the FDA product code for ACUSON I5100 ULTRASOUND TRANSDUCER?

The FDA product code for ACUSON I5100 ULTRASOUND TRANSDUCER is IYO.

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Other records listing Acuson Corp. 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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