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) (7) Calibrator, Hearing Aid / Earphone And Analysis Systems (ETW) (3)

Premarket Exempt

Yes No

Clear

Etymotic Research - 00846430004917 Catalog Number :

Device Description : DPOAE Probe System

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Etymotic Research - 00846430004924 Catalog Number :

Device Description : 10C amplifier

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

Etymotic Research - 00846430004931 Catalog Number :

Device Description : ER7 Series B Probe Microphone

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

Etymotic Research - 00846430004948 Catalog Number :

Device Description : ER7C series B Pre-Amplifier

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

Etymotic Research - 00846430004955 Catalog Number :

Device Description : ER7C series B MicrophoneER7C series B Pre-AmpER7-14 Probe Tubes

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

ER-1 - 00846430004962 Catalog Number :

Device Description : Insert Earphones for Research

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

ER-2 - 00846430004979 Catalog Number :

Device Description : Insert Earphone for Research

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430004986 Catalog Number :

Device Description : ER3C-10 Insert Earphone for Audiometry (10 ohm)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430004993 Catalog Number :

Device Description : ER-3C Insert Earphone (50 ohm)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005006 Catalog Number :

Device Description : ER30 Insert Earphones for Special Uses

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

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