MODEL 617 CARDIAC OUTPUT COMPUTER— 510(k) K870375

Substantially Equivalent

Omnimed B.V.

FDA 510(k) clearance K870375 for MODEL 617 CARDIAC OUTPUT COMPUTER, Substantially Equivalent on 1987-06-16. Applicant: Omnimed B.V.. Device class: 2.

Clearance details

Applicant: Omnimed B.V.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1987-01-29
Decision date: 1987-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: 2596 Bt S-Gravenhage, NL

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXG

K253092 — Argos Infinity (Rev. 1.0)2026-02-13
K251275 — VitalStream ART Connect; VitalStream-Hemo2025-09-26
K232048 — Cogent Hemodynamic Monitoring System; Cogent HMS2023-12-20
K212529 — Hypotension Decision Assist Model HDA-OR22021-11-23
K192169 — PulsioFlex Monitoring System with ProAQT Sensor2020-04-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.