CRITIKON CARDIAC OUTPUT COMPUTER— 510(k) K831967

Name: FDA 510(k) clearance K831967
Creator: U.S. Food and Drug Administration
Published: 1983-10-28

Substantially Equivalent

Critikon Company, LLC

FDA 510(k) clearance K831967 for CRITIKON CARDIAC OUTPUT COMPUTER, Substantially Equivalent on 1983-10-28. Applicant: Critikon Company, LLC. Device class: 2.

Clearance details

Applicant: Critikon Company, LLC
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 1983-06-20
Decision date: 1983-10-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DXG

view all

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

More clearances from Critikon Company, LLC

view all

K002248 — DINAMAP PRO 1000 MONITOR, MODEL 10002000-09-21
K000500 — DINAMAP ADVANCED NIBP MODULE2000-05-26
K992638 — DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 4002000-02-24
K982342 — DINAMAP MPS SELECT PORTABLE MONITOR1998-08-14
K943709 — DINAMAP PLUS VITAL SIGNS MONOITOR1995-06-16

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