CARESCAPE

Model D19KT VER01 · GE Healthcare Finland Oy · DI 00840682118262

BZK — Spirometer, Monitoring (W/Wo Alarm) · Class II · 21 CFR 868.1850

BZL — Computer, Oxygen-Uptake · Class II · 21 CFR 868.1730

BZQ — Monitor, Breathing Frequency · Class II · 21 CFR 868.2375

CAP — Monitor, Airway Pressure (Includes Gauge And/Or Alarm) · Class II · 21 CFR 868.2600

CBQ — Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500

CBR — Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1700

CBS — Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) · Class II · 21 CFR 868.1620

CCK — Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase · Class II · 21 CFR 868.1400

CCL — Analyzer, Gas, Oxygen, Gaseous-Phase · Class II · 21 CFR 868.1720

DPS — Electrocardiograph · Class II · 21 CFR 870.2340

DPZ — Oximeter, Ear · Class II · 21 CFR 870.2710

DQA — Oximeter · Class II · 21 CFR 870.2700

DQK — Computer, Diagnostic, Programmable · Class II · 21 CFR 870.1425

DRT — Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) · Class II · 21 CFR 870.2300

DSI — Detector And Alarm, Arrhythmia · Class II · 21 CFR 870.1025

DSJ — Alarm, Blood-Pressure · Class II · 21 CFR 870.1100

DSK — Computer, Blood-Pressure · Class II · 21 CFR 870.1110

DXG — Computer, Diagnostic, Pre-Programmed, Single-Function · Class II · 21 CFR 870.1435

DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130

FLL — Continuous Measurement Thermometer · Class II · 21 CFR 880.2910

GWJ — Stimulator, Auditory, Evoked Response · Class II · 21 CFR 882.1900

GWQ — Full-Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400

KOI — Stimulator, Nerve, Peripheral, Electric · Class II · 21 CFR 868.2775

KRB — Probe, Thermodilution · Class II · 21 CFR 870.1915

MHX — Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) · Class II · 21 CFR 870.1025

MLD — Monitor, St Segment With Alarm · Class II · 21 CFR 870.1025

NHO — Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500

NHP — Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500

NHQ — Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration) · Class II · 21 CFR 868.1500

OLT — Non-Normalizing Quantitative Electroencephalograph Software · Class II · 21 CFR 882.1400

OLW — Index-Generating Electroencephalograph Software · Class II · 21 CFR 882.1400

OMC — Reduced- Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400

ORT — Burst Suppression Detection Software For Electroencephalograph · Class II · 21 CFR 882.1400

UDILibrary device dossier · generated 2026-09-13 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.