HyperBand
K-Number: K162403 · 2016-11-18
ApplicantGe Medical Systems, LLC
Decision Date2016-11-18
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HyperBand is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2016-11-18 under approval number K162403. 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 HyperBand?
HyperBand is a medical device that received FDA 510(k) clearance on 2016-11-18. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K162403.
When was HyperBand approved by the FDA?
HyperBand received FDA 510(k) clearance on 2016-11-18, under approval number K162403.
What company makes HyperBand?
HyperBand is manufactured by Ge Medical Systems, LLC.
What is the FDA product code for HyperBand?
The FDA product code for HyperBand is LNH.
Other Devices by Ge Medical Systems, LLC
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K161795MAGNETOM ESSENZASiemens Medical Solutions USA, Inc.
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K161567SIGNA VoyagerGE Healthcare
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.