FDA 510(k)

UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM

K-Number: K122583 · 2012-09-05

Decision Date2012-09-05

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Samsung Medison Co., Ltd.. It received FDA 510(k) clearance on 2012-09-05 under 510(k) number K122583. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM?

UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-05. The listed applicant is Samsung Medison Co., Ltd.. The 510(k) number is K122583.

When did UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM receive FDA 510(k) clearance?

UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM received FDA 510(k) clearance on 2012-09-05, under 510(k) number K122583.

Who is the listed applicant for UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM?

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

What is the FDA product code for UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM?

The FDA product code for UGEO G60 DIAGNOSTIC ULTRASOUND SYSTEM is IYN.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.