CARESCAPE MONITOR B650

Registration Details

Registration Name: GE HEALTHCARE FINLAND OY
Registration Number: 9610105
FEI Number: 3002806783
Status: Active
Expiry Year: 2025
Initial Importer: No
Address: KUORTANEENKATU 2
City: HELSINKI Uusimaa
Country: FI

Regulatory Submissions

510(k) Number: K131223

Owner / Operator

Firm Name: GE HealthCare Technologies Inc.
Operator Number: 9912004
Address: 3000 N. Grandview Blvd
City: Waukesha
State: WI
Postal Code: 53188
Country: US

US Agent

Business Name: GE HealthCare Technologies, Inc
Contact Name: Tracey Holevas
Address: 3000 N. Grandview BLVD
City: Waukesha
State: WI
ZIP: 53188
Country: US
Email: [email protected]
Phone: 262 3092157

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Electrocardiograph	DPS	Class 2	Cardiovascular	No	2013-09-04
Index-Generating Electroencephalograph Software	OLW	Class 2	Neurology	No	2013-09-04
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	Class 2	Cardiovascular	No	2013-09-04
Alarm, Blood-Pressure	DSJ	Class 2	Cardiovascular	No	2013-09-04
Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	CBQ	Class 2	Anesthesiology	No	2013-09-04
System, Measurement, Blood-Pressure, Non-Invasive	DXN	Class 2	Cardiovascular	No	2013-09-04
Oximeter	DQA	Class 2	Cardiovascular	No	2013-09-04
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	Class 2	Anesthesiology	No	2013-09-04
Detector And Alarm, Arrhythmia	DSI	Class 2	Cardiovascular	No	2013-09-04
Analyzer, Gas, Oxygen, Gaseous-Phase	CCL	Class 2	Anesthesiology	No	2013-09-04
Reduced- Montage Standard Electroencephalograph	OMC	Class 2	Neurology	No	2013-09-04
Monitor, St Segment With Alarm	MLD	Class 2	Cardiovascular	No	2013-09-04
Spirometer, Monitoring (W/Wo Alarm)	BZK	Class 2	Anesthesiology	No	2013-09-04
Monitor, Airway Pressure (Includes Gauge And/Or Alarm)	CAP	Class 2	Anesthesiology	No	2013-09-04
Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	NHP	Class 2	Anesthesiology	No	2013-09-04
Continuous Measurement Thermometer	FLL	Class 2	General Hospital	No	2013-09-04
Computer, Diagnostic, Pre-Programmed, Single-Function	DXG	Class 2	Cardiovascular	No	2013-09-04
Non-Normalizing Quantitative Electroencephalograph Software	OLT	Class 2	Neurology	No	2013-09-04
Monitor, Breathing Frequency	BZQ	Class 2	Anesthesiology	No	2013-09-04
Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	NHQ	Class 2	Anesthesiology	No	2013-09-04
Computer, Blood-Pressure	DSK	Class 2	Cardiovascular	No	2013-09-04
Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	NHO	Class 2	Anesthesiology	No	2013-09-04
Full-Montage Standard Electroencephalograph	GWQ	Class 2	Neurology	No	2013-09-04
Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	CBR	Class 2	Anesthesiology	No	2013-09-04
Burst Suppression Detection Software For Electroencephalograph	ORT	Class 2	Neurology	No	2013-09-04
Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	CBS	Class 2	Anesthesiology	No	2013-09-04
Stimulator, Auditory, Evoked Response	GWJ	Class 2	Neurology	No	2013-09-04
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	Class 2	Cardiovascular	No	2013-09-04
Stimulator, Nerve, Peripheral, Electric	KOI	Class 2	Anesthesiology	No	2013-09-04
Computer, Diagnostic, Programmable	DQK	Class 2	Cardiovascular	No	2013-09-04
Probe, Thermodilution	KRB	Class 2	Cardiovascular	No	2013-09-04
Oximeter, Ear	DPZ	Class 2	Cardiovascular	No	2013-09-04
Computer, Oxygen-Uptake	BZL	Class 2	Anesthesiology	No	2013-09-04

Proprietary Names

CARESCAPE MONITOR B650 CARESCAPE Monitor B650-LI

Establishment Types

Manufacture Medical Device