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) (9) Calibrator, Hearing Aid / Earphone And Analysis Systems (ETW) (1)

Premarket Exempt

No Yes

Clear

N/A - 00846430004535 Catalog Number :

Device Description : 18mm foam ear tip 4pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430004542 Catalog Number :

Device Description : 4mm PVC ear tip 20pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430004559 Catalog Number :

Device Description : 4mm PVC ear tip 14pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430004566 Catalog Number :

Device Description : 4mm PVC ear tip 10pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430004573 Catalog Number :

Device Description : Infant silicone ear tip 100pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430004580 Catalog Number :

Device Description : Frost 3 flange ear tip (pair),13mm black foam ear tip (pair),Clear 3 flange ear Frost 3 flange ear tip (pair),13mm black foam ear tip (pair),Clear 3 flange ear tip (pair),10mm foam ear tip (pair)

Device Class : 2

Duns Number: 115380859

Premarket Exempt : Yes

Product Code : EWO

Prescription Use : No

Device Count : 1

Etymotic Research - 00846430004597 Catalog Number :

Device Description : ER1-14A foam ear tips with ER7-14C probe tubes

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : ETW

Prescription Use : No

Device Count : 1

N/A - 00846430004610 Catalog Number :

Device Description : Tubephone coupling tubes 4pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

N/A - 00846430004634 Catalog Number :

Device Description : Striped Red Tubing 100pk

Device Class :

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 100

N/A - 00846430004641 Catalog Number :

Device Description : Striped SoundTubing 4pk

Device Class : 2

Duns Number: 115380859

Premarket Exempt : No

Product Code : EWO

Prescription Use : No

Device Count : 1

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