SIGNAPioneer
K-Number: K160621 · 2016-03-29
ApplicantGE Healthcare
Decision Date2016-03-29
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNAPioneer is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2016-03-29 under approval number K160621. 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 SIGNAPioneer?
SIGNAPioneer is a medical device that received FDA 510(k) clearance on 2016-03-29. It is manufactured by GE Healthcare. The 510(k) number is K160621.
When was SIGNAPioneer approved by the FDA?
SIGNAPioneer received FDA 510(k) clearance on 2016-03-29, under approval number K160621.
What company makes SIGNAPioneer?
SIGNAPioneer is manufactured by GE Healthcare.
What is the FDA product code for SIGNAPioneer?
The FDA product code for SIGNAPioneer is LNH.
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Official Source
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