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FDA 510(k)

ViewPoint 6

K-Number: K162743 · 2016-11-22

Decision Date2016-11-22
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ViewPoint 6 is a medical device manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. It received FDA 510(k) clearance on 2016-11-22 under approval number K162743. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ViewPoint 6?

ViewPoint 6 is a medical device that received FDA 510(k) clearance on 2016-11-22. It is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics. The 510(k) number is K162743.

When was ViewPoint 6 approved by the FDA?

ViewPoint 6 received FDA 510(k) clearance on 2016-11-22, under approval number K162743.

What company makes ViewPoint 6?

ViewPoint 6 is manufactured by GE Medical Systems Ultrasound and Primary Care Diagnostics.

What is the FDA product code for ViewPoint 6?

The FDA product code for ViewPoint 6 is LLZ.

Other Devices by GE Medical Systems Ultrasound and Primary Care Diagnostics

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Related Devices (Code: LLZ)

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.