Orfit Aerial Couchtop
K-Number: K200282 · 2020-04-08
ApplicantOrfit Industries NV
Decision Date2020-04-08
Product CodeLHN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Orfit Aerial Couchtop is a medical device manufactured by Orfit Industries NV. It received FDA 510(k) clearance on 2020-04-08 under approval number K200282. The device is classified under product code LHN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Orfit Aerial Couchtop?
Orfit Aerial Couchtop is a medical device that received FDA 510(k) clearance on 2020-04-08. It is manufactured by Orfit Industries NV. The 510(k) number is K200282.
When was Orfit Aerial Couchtop approved by the FDA?
Orfit Aerial Couchtop received FDA 510(k) clearance on 2020-04-08, under approval number K200282.
What company makes Orfit Aerial Couchtop?
Orfit Aerial Couchtop is manufactured by Orfit Industries NV.
What is the FDA product code for Orfit Aerial Couchtop?
The FDA product code for Orfit Aerial Couchtop is LHN.
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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.