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
SUBSCRIBE / SIGN IN
K832092Substantially Equivalent

Electrocardiograph Machines, W/analyz

Fukuda Denshi USA, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K832092 is the FDA 510(k) clearance record for ELECTROCARDIOGRAPH MACHINES, W/ANALYZ, cleared for Fukuda Denshi USA, Inc. on . FDA records list 68 510(k) clearances for Fukuda Denshi USA, Inc., from to . As of , FDA records show no recalls naming K832092.

Clearance record

Decision date
Received
(190 days to decision)
Review panel
Unknown
Applicant
Fukuda Denshi USA, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No