The following data is part of a premarket notification filed by Mimosa Acoustics, Inc. with the FDA for Hearid+te Transient-evoked Otoacoustic Emissions Analyzer.
| Device ID | K063338 |
| 510k Number | K063338 |
| Device Name: | HEARID+TE TRANSIENT-EVOKED OTOACOUSTIC EMISSIONS ANALYZER |
| Classification | Audiometer |
| Applicant | MIMOSA ACOUSTICS, INC. 60 HAZELWOOD DR., SUITE #209 Champaign, IL 61820 |
| Contact | Patricia S Jeng |
| Correspondent | Patricia S Jeng MIMOSA ACOUSTICS, INC. 60 HAZELWOOD DR., SUITE #209 Champaign, IL 61820 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-06 |
| Decision Date | 2007-01-04 |