The following data is part of a premarket notification filed by Etymotic Research with the FDA for Ero Scan Oae Test System.
| Device ID | K010165 |
| 510k Number | K010165 |
| Device Name: | ERO SCAN OAE TEST SYSTEM |
| Classification | Audiometer |
| Applicant | ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007 |
| Contact | Steve Iseberg |
| Correspondent | Steve Iseberg ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-18 |
| Decision Date | 2001-03-12 |