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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K840232Substantially Equivalent

Abm Anesthesia & Brain Monitor

Datex Division Instrumentarium Corp., Helsinki 10 Finland / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840232 is the FDA 510(k) clearance record for ABM ANESTHESIA & BRAIN MONITOR, cleared for Datex Division Instrumentarium Corp. on . FDA records list 55 510(k) clearances for Datex Division Instrumentarium Corp., from to . As of , FDA records show no recalls naming K840232.

Clearance record

Decision date
Received
(87 days to decision)
Review panel
Unknown
Applicant
Datex Division Instrumentarium Corp. P.O. Box 357, Helsinki 10 Finland
Third party review
No