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

Protector, Hearing (Circumaural)

Unknown
FDA source (opens on fda.gov)

EWE is the FDA product code for Protector, Hearing (Circumaural). As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
EWE
Device name
Protector, Hearing (Circumaural)
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
1
Ingested recalls
0

Clearances, product code EWE

By decision year
1 clearance under product code EWE with a decision year between 1995 and 1995, 1995 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code EWE by decision year
YearClearances
19951

Applicants with the most clearances

Product code EWE
Applicants holding the most 510(k) clearances under product code EWE
ApplicantClearances
Bio-Logic Systems Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 18 companies shown, in name order