The following data is part of a premarket notification filed by Etymotic Research, Inc. with the FDA for Er35 Ero-scan Pro Hearing Test System.
| Device ID | K112733 |
| 510k Number | K112733 |
| Device Name: | ER35 ERO-SCAN PRO HEARING TEST SYSTEM |
| Classification | Audiometer |
| Applicant | ETYMOTIC RESEARCH, INC. 2001 PENNSYLVANIA AVE. NW SUITE 950 Washington, DC 20006 |
| Contact | Jack Kent |
| Correspondent | Jack Kent ETYMOTIC RESEARCH, INC. 2001 PENNSYLVANIA AVE. NW SUITE 950 Washington, DC 20006 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-20 |
| Decision Date | 2011-12-16 |
| Summary: | summary |