Device classification

Protector, Hearing (Circumaural)

Unknown

UnclassifiedProduct code EWE
Open FDA's page for this record
Third party flag
N
Life sustain support flag
N
Gmp exempt flag
N
Summary malfunction reporting
Eligible
Product code
EWE
Review panel
EN
Device name
Protector, Hearing (Circumaural)
Unclassified reason
1
Medical specialty description
Unknown
Device class
U
Implant flag
N
Submission type ID
7
Harmonized identifiers (openFDA)
Registration number
3006698500, 3014144373, 3006621348, 3002661124, 3016769292, 3030536686, 3006450239, 3015601315, 3012903018, 8022210, 3003627840, 3009845346, 3013598746, 3006713791, 3013152643, 3025759181, 3017067322, 1930027, 3038613785, 3042251637
FEI number
3006698500, 3014144373, 3006621348, 3002661124, 3016769292, 3030536686, 3006450239, 3015601315, 3012903018, 3003627840, 3932, 3009845346, 3013598746, 3006713791, 3013152643, 3025759181, 3017067322, 1930027, 3038613785, 3042251637
K number
K935160
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.