SIGNA Voyager
K-Number: K161567 · 2016-09-01
ApplicantGE Healthcare
Decision Date2016-09-01
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SIGNA Voyager is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2016-09-01 under approval number K161567. 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 Voyager?
SIGNA Voyager is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by GE Healthcare. The 510(k) number is K161567.
When was SIGNA Voyager approved by the FDA?
SIGNA Voyager received FDA 510(k) clearance on 2016-09-01, under approval number K161567.
What company makes SIGNA Voyager?
SIGNA Voyager is manufactured by GE Healthcare.
What is the FDA product code for SIGNA Voyager?
The FDA product code for SIGNA Voyager is LNH.
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Official Source
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