HiRise
K-Number: K203187 · 2020-11-18
ApplicantCurvebeam, LLC
Decision Date2020-11-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HiRise is a medical device manufactured by Curvebeam, LLC. It received FDA 510(k) clearance on 2020-11-18 under approval number K203187. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HiRise?
HiRise is a medical device that received FDA 510(k) clearance on 2020-11-18. It is manufactured by Curvebeam, LLC. The 510(k) number is K203187.
When was HiRise approved by the FDA?
HiRise received FDA 510(k) clearance on 2020-11-18, under approval number K203187.
What company makes HiRise?
HiRise is manufactured by Curvebeam, LLC.
What is the FDA product code for HiRise?
The FDA product code for HiRise is JAK.
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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.