Device |
aids, speech training for the hearing impaired (ac-powered and patient-contact) |
Review Panel |
Ear Nose & Throat |
Product Code | LEZ |
Premarket Review |
Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices
(OHT1)
Division of Dental and ENT Devices
(DHT1B)
|
Unclassified Reason
|
Pre-Amendment
|
Submission Type |
Enforcement Discretion
|
Device Class |
Unclassified
|
Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
GMP Exempt? |
No
|
Summary Malfunction Reporting |
Eligible |
Implanted Device? |
No
|
Life-Sustain/Support Device? |
No
|
Third Party Review |
Not Third Party Eligible |
|
|