510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K870375Substantially Equivalent

Model 617 Cardiac Output Computer

Omnimed B.V., 2596 Bt S-Gravenhage, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870375 is the FDA 510(k) clearance record for MODEL 617 CARDIAC OUTPUT COMPUTER, a class II device, cleared for Omnimed B.V. on under FDA product code DXG (Computer, Diagnostic, Pre-Programmed, Single-Function). FDA records list one 510(k) clearance for Omnimed B.V. As of , FDA records show no recalls naming K870375.

Clearance record

Decision date
Received
(138 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
Omnimed B.V. C/O Int'L Marketing Consultant, 2596 Bt S-Gravenhage, NL
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