FDA 510(k)

GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM

K-Number: K102104 · 2010-10-01

ApplicantWipro GE Healthcare Private, Ltd.

Decision Date2010-10-01

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Wipro GE Healthcare Private, Ltd.. It received FDA 510(k) clearance on 2010-10-01 under 510(k) number K102104. 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 GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM is a medical device that received FDA 510(k) clearance on 2010-10-01. The listed applicant is Wipro GE Healthcare Private, Ltd.. The 510(k) number is K102104.

When did GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM receive FDA 510(k) clearance?

GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM received FDA 510(k) clearance on 2010-10-01, under 510(k) number K102104.

Who is the listed applicant for GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

The FDA 510(k) record lists Wipro GE Healthcare Private, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM?

The FDA product code for GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING 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.