FDA 510(k)

MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND

K-Number: K092079 · 2009-08-06

ApplicantGe Medical Systems Israel, Ultrasound, Ltd.

Decision Date2009-08-06

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Israel, Ultrasound, Ltd.. It received FDA 510(k) clearance on 2009-08-06 under 510(k) number K092079. 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 MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND?

MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND is a medical device that received FDA 510(k) clearance on 2009-08-06. The listed applicant is Ge Medical Systems Israel, Ultrasound, Ltd.. The 510(k) number is K092079.

When did MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND receive FDA 510(k) clearance?

MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND received FDA 510(k) clearance on 2009-08-06, under 510(k) number K092079.

Who is the listed applicant for MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND?

The FDA 510(k) record lists Ge Medical Systems Israel, Ultrasound, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND?

The FDA product code for MODIFICATION TO GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND is IYN.

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Other records listing Ge Medical Systems Israel, Ultrasound, Ltd. as applicant

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Related Devices (Code: IYN)

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.