510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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LEZUnclassified

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

Unknown
FDA source (opens on fda.gov)

LEZ is the FDA product code for Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact). As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
LEZ
Device name
Aids, Speech Training For The Hearing Impaired (Ac-Powered And Patient-Contact)
Device class
Unclassified
Review panel
Unknown
Submission type
FDA code 7
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
1

Clearances, product code LEZ

By decision year
3 clearances under product code LEZ with a decision year between 1980 and 2009, 1980 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LEZ by decision year
YearClearances
19801
19981
20091

Applicants with the most clearances

Product code LEZ
Applicants holding the most 510(k) clearances under product code LEZ
ApplicantClearances
Kindel & Anderson1
Lsvt Global, LLC1
Rsq, LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code LEZ.