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

FDA Device Classification

FDA product code LEZ covers "Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)", a Class U medical device. Submissions are reviewed by the Unknown panel. At least 3 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LEZ
Device Class
Class U
Regulation Number
Submission Type
Review Panel
EN
Medical Specialty
Unknown
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K091682lsvt globalLSVT C OR LSVT COMPANION, MODEL V.1August 20, 2009
K982396rsqVISIVOX, MODEL V-2September 14, 1998
K802870kindel and andersonRION ELECTRO-PALATOGRAPH MODEL DP-01December 17, 1980

FDA data resources