The following data is part of a premarket notification filed by Mimosa Acoustics, Inc. with the FDA for Otostat Dpoae + Mepa Measurement System.
| Device ID | K123624 |
| 510k Number | K123624 |
| Device Name: | OTOSTAT DPOAE + MEPA MEASUREMENT SYSTEM |
| Classification | Audiometer |
| Applicant | MIMOSA ACOUSTICS, INC. 335 N Fremont St Champaign, IL 61820 |
| Contact | Patricia S Jeng |
| Correspondent | Patricia S Jeng MIMOSA ACOUSTICS, INC. 335 N Fremont St Champaign, IL 61820 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-23 |
| Decision Date | 2013-03-28 |
| Summary: | summary |