FDA 510(k)

ULTRASOUND SCANNER 501

K-Number: K834284 · 1984-05-09

Decision Date1984-05-09

Product CodeIYO

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ULTRASOUND SCANNER 501 is the device name listed in this FDA 510(k) record. The listed applicant is Imex Medical Systems, Inc.. It received FDA 510(k) clearance on 1984-05-09 under 510(k) number K834284. 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 ULTRASOUND SCANNER 501?

ULTRASOUND SCANNER 501 is a medical device that received FDA 510(k) clearance on 1984-05-09. The listed applicant is Imex Medical Systems, Inc.. The 510(k) number is K834284.

When did ULTRASOUND SCANNER 501 receive FDA 510(k) clearance?

ULTRASOUND SCANNER 501 received FDA 510(k) clearance on 1984-05-09, under 510(k) number K834284.

Who is the listed applicant for ULTRASOUND SCANNER 501?

The FDA 510(k) record lists Imex Medical Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ULTRASOUND SCANNER 501?

The FDA product code for ULTRASOUND SCANNER 501 is IYO.

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Other records listing Imex Medical Systems, Inc. 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.