Singapore HSA registration DE0005941
GE CARESCAPE Monitor B850
Singapore·CLASS C·GE Healthcare Finland Oy·Registered January 14, 2011Device classification
- Device Class
- CLASS C
- Medical Speciality Area
- General Hospital
Registration information
- Registration Number
- DE0005941
- Registration Date
- January 14, 2011
- Change Notification Approval Date
- August 07, 2024
- Retention Due Date
- January 13, 2026
Product description
Intended for use on adult, pediatric & neonatal patients. One patient at a time. For monitoring of: • hemodynamic (incl. ECG, ST segment, arrhythmia detection, ECG diagnostic analysis & measurement, invasive pressure, non-invasive blood pressure, pulse oximetry, regional oxygen saturation, total hemoglobin concentration, cardiac output (thermodilution & pulse contour), temperature, mixed venous oxygen saturation, central venous oxygen saturation, & Surgical Pleth Index), • respiratory (impedance respiration, airway gases (CO2, O2, N2O, and anesthetic agents), spirometry, gas exchange), • neurophysiological status (incl. electroencephalography, Entropy, Bispectral Index, and neuromuscular transmission). Intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional healthcare facility.
Product Owner
- Short Name
- GE Healthcare Finland Oy
- Address
- Kuortaneenkatu 2, FI-00510 Helsinki, FINLAND
Registrant
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Importer
- Address
- 11 NORTH BUONA VISTA DRIVE, THE METROPOLIS, #11-07, SINGAPORE 138589
Model information
- Model Name(s)
- CPU-C1 CARESCAPE MONITOR B850 CPU-C1 CARESCAPE MONITOR B850 CARESCAPE Life Upgrade Program for AM to CARESCAPE Monitor B850 CARESCAPE Life Upgrade Program for CCM to CARESCAPE Monitor B850 CARESCAPE Life Upgrade Program for Solar 8000, Solar 8000i and Solar 8000M to CARESCAPE Monitor B850 CARESCAPE UPGRADE SOLAR 9500 TO B850 CPU-C1 CARESCAPE MONITOR B850 CPU-C1 CARESCAPE MONITOR B850 CPU-C1 CARESCAPE MONITOR B850 B850 third video upgrade BX50 ESP V2 UPGRADE ENGLISH INTL BX50 ESP V2 UPGRADE ENGLISH INTL Bx50 ESP V2 UPGRADE ENGLISH INTL E-EEGX N-EEGX Carescape RAD Gas Sampling Line, disposable, PVC/PE, 2m/7ft Gas Sampling Line, disposable, PVC/PE, 3m/10ft Gas Sampling Line, disposable, PVC/PE, 6m/20ft E-musb CARESCAPE B850 CARESCAPE B850 B850 CPU WITH ONE DISPLAY SUPPORT B850 CPU WITH TWO DISPLAY SUPPORT F7 Frame F5 Frame PiCCO Continuous Cardiac Output Cable, 4.1m PiCCO Injectate Sensor Cable, 0.9m E-PiCCO-00 E-sCAIOVX-00 E-sCOVX-00
- Model Identifier(s)
- 2020913-004 2020913-005 2042396-083 2042396-084 2042396-085 2042396-086 2042396-140 2042396-141 2042396-142 2050032-001 2068086-151 2068086-251 2068086-451 2080993-004 2080994-004 2096726-001 2097307-001 2097307-002 2097307-003 5513682 5514366 5805690 5818089 5818090 M1115509 M1115512 M1154585 M1182448 M1187062 M1199234 M1199507
About this record
Access comprehensive regulatory information for GE CARESCAPE Monitor B850 in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0005941 and owned by GE Healthcare Finland Oy. The device was registered on January 14, 2011.
This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.
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