510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K833024Substantially Equivalent

Oftalmograf

Universal Instruments Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833024 is the FDA 510(k) clearance record for OFTALMOGRAF, cleared for Universal Instruments Corp. on . FDA records list 2 510(k) clearances for Universal Instruments Corp., from to . As of , FDA records show no recalls naming K833024.

Clearance record

Decision date
Received
(233 days to decision)
Review panel
Unknown
Applicant
Universal Instruments Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No