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FDA 510(k)

MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS

K-Number: K003121 · 2000-10-20

ApplicantMedison America, Inc.
Decision Date2000-10-20
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS is the device name listed in this FDA 510(k) record. The listed applicant is Medison America, Inc.. It received FDA 510(k) clearance on 2000-10-20 under 510(k) number K003121. 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 MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS?

MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS is a medical device that received FDA 510(k) clearance on 2000-10-20. The listed applicant is Medison America, Inc.. The 510(k) number is K003121.

When did MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS receive FDA 510(k) clearance?

MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS received FDA 510(k) clearance on 2000-10-20, under 510(k) number K003121.

Who is the listed applicant for MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS?

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

What is the FDA product code for MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS?

The FDA product code for MYSONO 201 DIAGNOSTIC ULTRASOUND AND TRANSDUCERS 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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