MOBERG RESEARCH INC

Address:224 S Maple St,Ambler,PA,19002,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Amplitude-Integrated Electroencephalograph (OMA) (10) Burst Suppression Detection Software For Electroencephalograph (ORT) (10) Full-Montage Standard Electroencephalograph (GWQ) (10) Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) (MHX) (10) Non-Normalizing Quantitative Electroencephalograph Software (OLT) (10) Oximeter, Tissue Saturation (MUD) (10)

Premarket Exempt

Clear

Component Neuromonitoring System - B485CNS3001 Catalog Number :

Device Description : Domestic (U.S.) model; a portable, computer-based system that can continuously r Domestic (U.S.) model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : GWQ, ORT, MHX, OMA, MUD, OLT

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNS3101 Catalog Number :

Device Description : Research model; a portable, computer-based system that can continuously record, Research model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : OLT, MUD, OMA, MHX, ORT, GWQ

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNS3201 Catalog Number :

Device Description : International (non-U.S.) model; a portable, computer-based system that can conti International (non-U.S.) model; a portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : GWQ, ORT, MHX, OMA, MUD, OLT

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNS3501 Catalog Number :

Device Description : A portable, computer-based system that can continuously record, display, store a A portable, computer-based system that can continuously record, display, store and analyze physiological data from multiple monitoring sources in real time.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : GWQ, ORT, MHX, OMA, MUD, OLT

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNSEEG2001 Catalog Number :

Device Description : Optional 16 input EEG amplifier for direct recording of EEG and other physiologi Optional 16 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : GWQ, ORT, MHX, OMA, OLT, MUD

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNSEEG2101 Catalog Number :

Device Description : Research model; optional 16 input EEG amplifier for direct recording of EEG and Research model; optional 16 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : OMA, MUD, OLT, MHX, ORT, GWQ

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNSEEG2201 Catalog Number :

Device Description : International (non-U.S.) model; optional 16 input EEG amplifier for direct recor International (non-U.S.) model; optional 16 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : GWQ, ORT, MHX, OMA, OLT, MUD

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNSEEG3001 Catalog Number :

Device Description : Optional 40 input EEG amplifier for direct recording of EEG and other physiologi Optional 40 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : MUD, OLT, OMA, MHX, ORT, GWQ

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNSEEG3101 Catalog Number :

Device Description : Research model; optional 40 input EEG amplifier for direct recording of EEG and Research model; optional 40 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : GWQ, ORT, MHX, OMA, OLT, MUD

Prescription Use : No

Device Count : 1

Component Neuromonitoring System - B485CNSEEG3201 Catalog Number :

Device Description : International (non-U.S.) model; optional 40 input EEG amplifier for direct recor International (non-U.S.) model; optional 40 input EEG amplifier for direct recording of EEG and other physiological signals from the patient.

Device Class : 2

Duns Number: 029957656

Premarket Exempt : No

Product Code : MUD, OLT, OMA, MHX, ORT, GWQ

Prescription Use : No

Device Count : 1

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