Discovery MI Gen2
K-Number: K211846 · 2021-08-20
ApplicantGe Medical Systems, LLC
Decision Date2021-08-20
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Discovery MI Gen2 is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2021-08-20 under approval number K211846. 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 Gen2?
Discovery MI Gen2 is a medical device that received FDA 510(k) clearance on 2021-08-20. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K211846.
When was Discovery MI Gen2 approved by the FDA?
Discovery MI Gen2 received FDA 510(k) clearance on 2021-08-20, under approval number K211846.
What company makes Discovery MI Gen2?
Discovery MI Gen2 is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for Discovery MI Gen2?
The FDA product code for Discovery MI Gen2 is KPS.
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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.