510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K922394Substantially Equivalent

Cardiofax Q ECG-8420A

Nihon Kohden America Inc, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K922394 is the FDA 510(k) clearance record for CARDIOFAX Q ECG-8420A, cleared for Nihon Kohden America, Inc. on under FDA product code LOS. FDA records list 166 510(k) clearances for Nihon Kohden America, Inc., from to . As of , FDA records show no recalls naming K922394.

Clearance record

Decision date
Received
(650 days to decision)
Product code
LOS
Review panel
Unknown
Applicant
Nihon Kohden America, Inc. 2601 Campus Dr., Irvine CA
510(k) summary
Statement
Third party review
No

Clearances, product code LOS

Trailing 12 months

FDA records hold no clearances under product code LOS in the trailing twelve months.

FDA records show no clearances under product code LOS in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LOS, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260