510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861415Substantially Equivalent

Canon Auto Ref Keratometer Rk-1

Canon Medical Components U.S.A., Inc., Jericho NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861415 is the FDA 510(k) clearance record for CANON AUTO REF KERATOMETER RK-1, cleared for Canon USA, Inc. on . FDA records list 48 510(k) clearances for Canon Medical Components U.S.A., Inc., from to . As of , FDA records show no recalls naming K861415.

Clearance record

Decision date
Received
(29 days to decision)
Review panel
Unknown
Applicant
Canon USA, Inc. One Jericho Plz., Jericho NY
Third party review
No