510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K854169Substantially Equivalent

Pupilscan

Fairville Medical Optics, Inc., Montchanin DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854169 is the FDA 510(k) clearance record for PUPILSCAN, cleared for Fairville Medical Optics, Inc. on . FDA records list one 510(k) clearance for Fairville Medical Optics, Inc. As of , FDA records show no recalls naming K854169.

Clearance record

Decision date
Received
(62 days to decision)
Review panel
Unknown
Applicant
Fairville Medical Optics, Inc. Box 282, Montchanin DE
Third party review
No