I am trying to rationalize our device as Class I.
The device, an insert earphone, is an accessory for an audiometer. Audiometers are generally Class IIa.
The device is used inside the ear canal, is intended to touch only intact skin, and is commonly in contact for less than 1 hour (transient use).
Regardless, it seems that rule 5 would make this device Class IIa since it connects to an audiometer.
Does the fact that it is an accessory change the way I can rationalize it?
Also, the MHRA has "Auditory Testing Headphones and Accessories" (code Z172), and "Electrodes/Transducers and Accessories" (code C2) as Class I devices.
Does this strengthen my Class I rationalization?
The device, an insert earphone, is an accessory for an audiometer. Audiometers are generally Class IIa.
The device is used inside the ear canal, is intended to touch only intact skin, and is commonly in contact for less than 1 hour (transient use).
Regardless, it seems that rule 5 would make this device Class IIa since it connects to an audiometer.
Does the fact that it is an accessory change the way I can rationalize it?
Also, the MHRA has "Auditory Testing Headphones and Accessories" (code Z172), and "Electrodes/Transducers and Accessories" (code C2) as Class I devices.
Does this strengthen my Class I rationalization?