SIGNA Premier
K-Number: K183231 · 2019-01-18
ApplicantGe Medical Systems, LLC
Decision Date2019-01-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Premier is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2019-01-18 under approval number K183231. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SIGNA Premier?
SIGNA Premier is a medical device that received FDA 510(k) clearance on 2019-01-18. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K183231.
When was SIGNA Premier approved by the FDA?
SIGNA Premier received FDA 510(k) clearance on 2019-01-18, under approval number K183231.
What company makes SIGNA Premier?
SIGNA Premier is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for SIGNA Premier?
The FDA product code for SIGNA Premier is LNH.
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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.