510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943256Substantially Equivalent

Cardiac Output Option 39

Medical Data Electronics, Arleta CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943256 is the FDA 510(k) clearance record for CARDIAC OUTPUT OPTION 39, a class II device, cleared for Medical Data Electronics on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list 27 510(k) clearances for Medical Data Electronics, from to . As of , FDA records show no recalls naming K943256.

Clearance record

Decision date
Received
(162 days to decision)
Product code
DXG Computer, Diagnostic, Pre-Programmed, Single-Function
Regulation
21 CFR 870.1435
Device class
Class II
Review panel
Cardiovascular
Applicant
Medical Data Electronics 12720 Wentworth St., Arleta CA
510(k) summary
Statement
Third party review
No

Clearances, product code DXG

Trailing 12 months
1 clearance under product code DXG in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260