Last synced on 25 November 2022 at 11:04 pm

Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

Page Type
Product Code
Review Panel
Ear, Nose, Throat
Submission Type
Enforcement Discretion
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code LEZ is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.

Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)

Page Type
Product Code
Review Panel
Ear, Nose, Throat
Submission Type
Enforcement Discretion
Device Classification
U
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code LEZ is assigned to devices that are "unclassified" (e.g. pre-amendment), it is not linked to any specific regulation and CFR section.