The following data is part of a premarket notification filed by Etymotic Research with the FDA for Ero-scan Otoacoustic Emissions Test Inst. (er34).
| Device ID | K980533 |
| 510k Number | K980533 |
| Device Name: | ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) |
| Classification | Audiometer |
| Applicant | ETYMOTIC RESEARCH 511 SILVER LAKE DR. Danville, CA 94526 |
| Contact | Krista M Buckles, M.a. |
| Correspondent | Krista M Buckles, M.a. ETYMOTIC RESEARCH 511 SILVER LAKE DR. Danville, CA 94526 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-02-11 |
| Decision Date | 1998-03-23 |
| Summary: | summary |