ER36 Series OAE Test System
ETYMOTIC RESEARCH, INC.
ETYMOTIC RESEARCH, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1450042 | 1450042 | ETYMOTIC RESEARCH, INC. | 1 | N | 2026-01-01 | 1125 Remington Road Schaumburg IL US 60173 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 31489 | 1459996733 | K980533 | ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) | EWO | 1998-03-23 |
| 31489 | 1040407835 | K930553 | CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT | EWO | 1993-09-29 |
| 31489 | 1297925356 | K930003 | TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES | EWO | 1993-06-18 |
| 31489 | 1202179104 | K873298 | ELEC-TIP | GXY | 1987-11-24 |
| 31489 | 1122920858 | K861113 | ER-7C CLINICAL PROBE MICROPHONE | ETW | 1986-04-23 |
| 31489 | 1135283915 | K180287 | GSI Corti | EWO | 2018-05-11 |
| 31489 | 1158404467 | K150491 | ER36 Series OAE Test System | EWO | 2015-03-26 |
| 31489 | 1673319761 | K112733 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | EWO | 2011-12-16 |
| 31489 | 1232845390 | K070880 | ER35 ERO-SCAN PRO HEARING TEST SYSTEM | EWO | 2007-06-07 |
| 31489 | 1513383125 | K011114 | ETYMOTIC RESEARCH ER-10D OAE PROBE | EWO | 2001-07-03 |
| 31489 | 1491069109 | K010165 | ERO SCAN OAE TEST SYSTEM | EWO | 2001-03-12 |
| 31489 | 1535569015 | ||||
| 31489 | 1938793132 | ||||
| 31489 | 1198518186 | ||||
| 31489 | 1899409289 | ||||
| 31489 | 1910635727 | ||||
| 31489 | 1943579986 | ||||
| 31489 | 2035627435 |
Product Codes Associated With Registrations#
PMN#
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
ETYMOTIC RESEARCH, INC.
ER35 ERO-SCAN PRO HEARING TEST SYSTEM
ETYMOTIC RESEARCH, INC.
ETYMOTIC RESEARCH ER-10D OAE PROBE
ETYMOTIC RESEARCH
ERO SCAN OAE TEST SYSTEM
ETYMOTIC RESEARCH
ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34)
ETYMOTIC RESEARCH
CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT
ETYMOTIC RESEARCH
TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES
ETYMOTIC RESEARCH
ELEC-TIP
ETYMOTIC RESEARCH
ER-7C CLINICAL PROBE MICROPHONE
ETYMOTIC RESEARCH
K-BASS LO FREQUENCY HEARING AID
ETYMOTIC RESEARCH
GUDID#
N/A - 10mm foam ear tip 50pk
2016-09-19
N/A - Foam 13 mm (adult) ear tip 10/pk sample
2018-05-11
N/A - Standard black foam eartip (5 pair)
2016-10-11
N/A - Various size eartips (156/pk)
2016-10-11
N/A - 10mm foam ear tip 36pk
2016-09-19
N/A - 13mm horn foam ear tip 36pk
2016-09-19
N/A - Frost 3 flange ear tip (pair),13mm black foam ear tip (pair),Clear 3 flange ear tip (pair),10mm foam ear tip (pair)
2016-09-19
N/A - Infant silicone ear tip 100pk
2016-09-19
N/A - 4mm PVC ear tip 10pk
2016-09-19
N/A - 4mm PVC ear tip 14pk
2016-09-19
N/A - 4mm PVC ear tip 20pk
2016-09-19
N/A - 18mm foam ear tip 4pk
2016-09-19
N/A - 18mm foam ear tip 2pk
2016-09-19
N/A - 18mm foam ear tip 24pk
2016-09-19
N/A - 3.5mm PVC ear tip 10pk
2016-09-19
N/A - 3.5mm PVC ear tip 14pk
2016-09-19
N/A - 3.5mm PVC ear tip 20pk
2016-09-19
N/A - 10mm foam ear tip 10pk
2016-09-19
N/A - 10mm foam ear tip 20pk
2016-09-19
N/A - 13mm foam eartips without tubes
2016-09-19
N/A - 13mm foam ear tip 500pk
2016-09-19
N/A - 13mm foam ear tip 20pk
2016-09-19
N/A - 13mm foam ear tip 50pk
2016-09-19
N/A - 18mm foam ear tip 24pk
2016-09-19
N/A - 10mm foam ear tip 20pk
2016-09-19
N/A - 10mm foam ear tip 50pk
2016-09-19
N/A - 13mm foam ear tip 50pk
2016-09-19
N/A - 10mm foam ear tip 13pk
2016-09-19
N/A - 13mm foam ear tip 50pk
2016-09-19
N/A - 6mm ear tip 20pk
2016-09-19
N/A - 5mm ear tip 20pk
2016-09-19
N/A - 4mm ear tip 20pk
2016-09-19
N/A - 3.5mm ear tip 20pk
2016-09-19
N/A - Tri-lumen silicone ear tip tubes 50pk
2016-09-19
N/A - 18mm foam eartip
2016-09-19
N/A - 18mm foam eartip
2016-09-19
N/A - 18mm foam eartip
2016-09-19
N/A - 10mm foam eartip
2016-09-19
N/A - 10mm foam eartip
2016-09-19
N/A - 10mm foam eartip
2016-09-19