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FDA 510(k)

ViewPoint 6

K-Number: K203677 · 2021-01-15

ApplicantGE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Decision Date2021-01-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ViewPoint 6 is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. It received FDA 510(k) clearance on 2021-01-15 under 510(k) number K203677. 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 2021-01-15. The listed applicant is GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC. The 510(k) number is K203677.

When did ViewPoint 6 receive FDA 510(k) clearance?

ViewPoint 6 received FDA 510(k) clearance on 2021-01-15, under 510(k) number K203677.

Who is the listed applicant for ViewPoint 6?

The FDA 510(k) record lists GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ViewPoint 6?

The FDA product code for ViewPoint 6 is LLZ.

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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.

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