510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K852504Substantially Equivalent

Ohmeda Cpu Monitor

GE Healthcare, Madison WI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852504 is the FDA 510(k) clearance record for OHMEDA CPU MONITOR, cleared for Ohmeda Medical on . FDA records list 888 510(k) clearances for GE HEALTHCARE, from to . As of , FDA records show no recalls naming K852504.

Clearance record

Decision date
Received
(19 days to decision)
Review panel
Unknown
Applicant
Ohmeda Medical Ohmeda Dr., Madison WI
Third party review
No