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SURGICAL MICROSCOPE SYSTEM ORBEYE with IR — Olympus Medical Systems Corp. (510(k) K190772)

SURGICAL MICROSCOPE SYSTEM ORBEYE with IR — Olympus Medical Systems Corp. (510(k) K190772) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: SURGICAL MICROSCOPE SYSTEM ORBEYE with IR; Applicant: Olympus Medical Systems Corp.; Clearance track: 510(k).

Device nameSURGICAL MICROSCOPE SYSTEM ORBEYE with IR
ApplicantOlympus Medical Systems Corp.
Clearance track510(k)
Submission numberK190772
DecisionSubstantially Equivalent
Decision date2019-10-10
Date received2019-03-26
Product codeIZI
Device class2
Medical specialtyRadiology
Applicant locationJP
SourceopenFDA device

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