FDA 510(k)

GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND

K-Number: K071985 · 2007-08-17

Decision Date2007-08-17

Product CodeIYN

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 2007-08-17 under 510(k) number K071985. 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 S5 AND S6 DIAGNOSTIC ULTRASOUND?

GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND is a medical device that received FDA 510(k) clearance on 2007-08-17. The listed applicant is General Electric Co.. The 510(k) number is K071985.

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

GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND received FDA 510(k) clearance on 2007-08-17, under 510(k) number K071985.

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

The FDA 510(k) record lists General Electric Co. as the applicant. This does not by itself establish the device manufacturer.

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

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

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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.