TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM— 510(k) K113821

Name: FDA 510(k) clearance K113821
Creator: U.S. Food and Drug Administration
Published: 2012-09-07

Substantially Equivalent

Transonic Systems, Inc.

FDA 510(k) clearance K113821 for TRANSONIC COSTATUS CARDIAC OUTPUT SYSTEM, Substantially Equivalent on 2012-09-07. Applicant: Transonic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Transonic Systems, Inc.
Product code: Code DXG
Device class: Class 2
Regulation: 21 CFR 870.1435
Advisory panel: Cardiovascular
Date received: 2011-12-27
Decision date: 2012-09-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ithaca, NY, 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 Transonic Systems, Inc.

view all

K140740 — TRANSONIC TISSUE PERFUSION MONITOR2015-07-23
K134051 — TRANSONIC ELSA SYSTEM2015-01-29
K134035 — TRANSONIC HCM 103 SYSTEM2014-09-17
K140017 — TRANSONIC HCM 102 SYSTEM2014-09-16
K112657 — AUREFLO MONITORING SYSTEM2011-12-21

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