Device |
hearing aid, bone conduction |
Regulation Description |
Hearing Aid. |
Regulation Medical Specialty |
Ear Nose & Throat |
Review Panel |
Ear Nose & Throat |
Product Code | LXB |
Premarket Review |
Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices
(DHT1C)
|
Submission Type |
510(k)
|
Regulation Number |
874.3300
|
Device Class |
2
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Recognized Consensus Standards
|
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review
|
Accredited Persons
|
|
|