The following data is part of a premarket notification filed by Etymotic Research, Inc. with the FDA for Er36 Series Oae Test System.
| Device ID | K150491 |
| 510k Number | K150491 |
| Device Name: | ER36 Series OAE Test System |
| Classification | Audiometer |
| Applicant | ETYMOTIC RESEARCH, INC. 61 MARTIN LN. Elk Grove Village, IL 60007 |
| Contact | Steve Iseberg |
| Correspondent | Meaghan Bailey NSF HEALTH SCIENCES MEDICAL DEVICES 2001 PENNSYLVANIA AVE. N.W. SUITE 950 Washington, DC 20006 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-25 |
| Decision Date | 2015-03-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846430005365 | K150491 | 000 |
| 00846430005358 | K150491 | 000 |
| 04260176120148 | K150491 | 000 |