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) (4) Electrode, Cutaneous (GXY) (1)

Premarket Exempt

Yes No

Clear

Etymotic - 00846430005396 Catalog Number :

Device Description : ER3-60 Gold Eartip Electrode Cable with Snap Connector

Device Class : 2

Duns Number: 115380859

Premarket Exempt : Yes

Product Code : GXY

Prescription Use : Yes

Device Count : 1

Etymotic Research - 00846430005402 Catalog Number :

Device Description : Blue and Red ER-3 Tubes

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

Etymotic Research - 00846430005419 Catalog Number :

Device Description : Clear ER-3 Tubes - 6pack

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005440 Catalog Number :

Device Description : ER3C-300 System consists of the following items:ER3C-300 Audiometric Insert Earp ER3C-300 System consists of the following items:ER3C-300 Audiometric Insert Earphones,ER3C-84 7' cable with dual-mono 6.33 mm (1/4") plugs or ER3-19 Cable Shielded 300 Ohm 16' (ABR) or ER3-31 Shielded (ABR) Cable, or ER3-32 Shielded (ABR) Cable,ER3C-14A foam eartips (regular, 13 mm),ER3C-14B foam eartips (small, 10 mm),ER3C-14C foam eartips (large, 18 mm)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

N/A - 00846430005488 Catalog Number :

Device Description : ER3C-300 ohm Audiometric Insert Earphone

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : Yes

Device Count : 1

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