ETYMOTIC RESEARCH, INC.

ETYMOTIC RESEARCH, INC.

Address:61 Martin Ln,ELK GROVE VILLAGE,IL,60007,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Audiometer (EWO) (8) Electrode, Cutaneous (GXY) (2)

Premarket Exempt

No Yes

Clear

Etymotic Research, Inc. - 00846430004009 Catalog Number :

Device Description : Changing tool with filters(orange) HHT

Device Class :

Duns Number: 115380859

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 4

Etymotic - 00846430004016 Catalog Number :

Device Description : Replacement Filters 6pk-orange

Device Class :

Duns Number: 115380859

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 6

Etymotic Research, Inc. - 00846430004023 Catalog Number :

Device Description : Home Hearing Test

Device Class : 2

Duns Number: 115380859

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Etymotic Research - 00846430004047 Catalog Number :

Device Description : Gold Electrode Eartips 13mm 20/pk

Device Class :

Duns Number: 115380859

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 20

Etymotic Research - 00846430004061 Catalog Number :

Device Description : Gold Electrode Eartips 10mm 20/pkg

Device Class :

Duns Number: 115380859

Premarket Exempt : No

Product Code : GXY

Prescription Use : No

Device Count : 20

Single Use Eartip - 00846430004078 Catalog Number :

Device Description : 3mm Single Use Eartip 100pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Single Use Eartip - 00846430004085 Catalog Number :

Device Description : 4mm Ear tip 100pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Single Use Eartip - 00846430004092 Catalog Number :

Device Description : 5mm Single Use Eartip 100pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Single Use Eartip - 00846430004108 Catalog Number :

Device Description : 6mm Single Use Ear tip 100pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

Single Use Eartip - 00846430004115 Catalog Number :

Device Description : 7mm Single Use Ear tip 100pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

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