Universal Viewer
K-Number: K211312 · 2021-05-21
ApplicantGE Healthcare
Decision Date2021-05-21
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Universal Viewer is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2021-05-21 under approval number K211312. 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 Universal Viewer?
Universal Viewer is a medical device that received FDA 510(k) clearance on 2021-05-21. It is manufactured by GE Healthcare. The 510(k) number is K211312.
When was Universal Viewer approved by the FDA?
Universal Viewer received FDA 510(k) clearance on 2021-05-21, under approval number K211312.
What company makes Universal Viewer?
Universal Viewer is manufactured by GE Healthcare.
What is the FDA product code for Universal Viewer?
The FDA product code for Universal Viewer 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.