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) (10)

Premarket Exempt

Yes No

Clear

ER-1 - 00846430005020 Catalog Number :

Device Description : ER1 pair,ER1-21,ER1-14A,ER1-14B-S

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

ER-2 - 00846430005037 Catalog Number :

Device Description : ER-2 Insert Earphone (pair),ER1-21,ER1-14A,ER1-14B-S

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005044 Catalog Number :

Device Description : ER3C-10 insert earphone (pair)ER3-21 audiometric tubing,ER003452AR foam ear tips ER3C-10 insert earphone (pair)ER3-21 audiometric tubing,ER003452AR foam ear tips (13mm),ER003453AR foam ear tips (10mm),ER003454AR foam ear tips (18mm)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005051 Catalog Number :

Device Description : ER3C-50 Insert Earphone (pair)ER3-21 audiometric tubing,ER003452AR foam ear tips ER3C-50 Insert Earphone (pair)ER3-21 audiometric tubing,ER003452AR foam ear tips (13mm)ER003453AR foam ear tips (10mm)ER003454AR foam ear tips (18mm)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005068 Catalog Number :

Device Description : 10B+ Low Noise Microphone

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005075 Catalog Number :

Device Description : ER30 Earphone (pair),ER30-18 tubing with adapters,ER13-14 foam ear tips (13mm), ER30 Earphone (pair),ER30-18 tubing with adapters,ER13-14 foam ear tips (13mm),ER13-14B foam ear tips (10mm)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005198 Catalog Number :

Device Description : 13mm horn foam ear tip 36pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005204 Catalog Number :

Device Description : 10mm foam ear tip 36pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005211 Catalog Number :

Device Description : Various size eartips (156/pk)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430005266 Catalog Number :

Device Description : Standard black foam eartip (5 pair)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

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