Sapphire II PRO
K-Number: K200269 · 2020-03-04
ApplicantOrbusneich Medical Trading, Inc.
Decision Date2020-03-04
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Sapphire II PRO is a medical device manufactured by Orbusneich Medical Trading, Inc.. It received FDA 510(k) clearance on 2020-03-04 under approval number K200269. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sapphire II PRO?
Sapphire II PRO is a medical device that received FDA 510(k) clearance on 2020-03-04. It is manufactured by Orbusneich Medical Trading, Inc.. The 510(k) number is K200269.
When was Sapphire II PRO approved by the FDA?
Sapphire II PRO received FDA 510(k) clearance on 2020-03-04, under approval number K200269.
What company makes Sapphire II PRO?
Sapphire II PRO is manufactured by Orbusneich Medical Trading, Inc..
What is the FDA product code for Sapphire II PRO?
The FDA product code for Sapphire II PRO is LOX.
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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.