The following data is part of a premarket notification filed by Etymotic Research with the FDA for Etymotic Research Er-10d Oae Probe.
| Device ID | K011114 |
| 510k Number | K011114 |
| Device Name: | ETYMOTIC RESEARCH ER-10D OAE PROBE |
| Classification | Audiometer |
| Applicant | ETYMOTIC RESEARCH 61 MARTIN LN. Elk Grove Village, IL 60007 |
| Contact | Erik Gundersen |
| Correspondent | Erik Gundersen 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 | 2001-04-12 |
| Decision Date | 2001-07-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846430005297 | K011114 | 000 |