I just need the answer for Portable EEG, please let me know the class, type
Equipment |
Type |
Patient circuit |
Class |
Toaster |
B |
NO |
1 |
EEG(Portable) |
? |
yes |
? |
For a portable EEG equipment, the following is the Type, patient circuit and class:
1. Type: For a portable EEG equipment, it is a type BF equipment.
This is because the type BF class of medical devices are the ones who has direct contact with patient's body parts for a short or medium amunt of time. Therefore the portable EEG is a Type BF equipment, which has conductive elecrical conact for electroencephalogram .
2. Class: Class
2
Class 2 medical devices are FDA approved medical devicesas they have low to moderate risk of adverse events and it is due to electrical impulse stimulation probability of the medical equipment for EEG in class 2 Therefore a portable EEG is a Class 2 medical equipment.
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