SURGICAL MICROSCOPE SYSTEM ORBEYE with IR
K-Number: K190772 · 2019-10-10
ApplicantOlympus Medical Systems Corp.
Decision Date2019-10-10
Product CodeIZI
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR is a medical device manufactured by Olympus Medical Systems Corp.. It received FDA 510(k) clearance on 2019-10-10 under approval number K190772. The device is classified under product code IZI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SURGICAL MICROSCOPE SYSTEM ORBEYE with IR?
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR is a medical device that received FDA 510(k) clearance on 2019-10-10. It is manufactured by Olympus Medical Systems Corp.. The 510(k) number is K190772.
When was SURGICAL MICROSCOPE SYSTEM ORBEYE with IR approved by the FDA?
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR received FDA 510(k) clearance on 2019-10-10, under approval number K190772.
What company makes SURGICAL MICROSCOPE SYSTEM ORBEYE with IR?
SURGICAL MICROSCOPE SYSTEM ORBEYE with IR is manufactured by Olympus Medical Systems Corp..
What is the FDA product code for SURGICAL MICROSCOPE SYSTEM ORBEYE with IR?
The FDA product code for SURGICAL MICROSCOPE SYSTEM ORBEYE with IR is IZI.
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Official Source
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