Discovery MI
K-Number: K161574 · 2016-08-11
ApplicantGe Medical Systems, LLC
Decision Date2016-08-11
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Discovery MI is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-08-11 under approval number K161574. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Discovery MI?
Discovery MI is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K161574.
When was Discovery MI approved by the FDA?
Discovery MI received FDA 510(k) clearance on 2016-08-11, under approval number K161574.
What company makes Discovery MI?
Discovery MI is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for Discovery MI?
The FDA product code for Discovery MI is KPS.
Other Devices by Ge Medical Systems, LLC
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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.