The following data is part of a premarket notification filed by Mimosa Acoustics, Inc. with the FDA for Cub Dis Ii Dpoae Measurement System.
| Device ID | K981460 |
| 510k Number | K981460 |
| Device Name: | CUB DIS II DPOAE MEASUREMENT SYSTEM |
| Classification | Audiometer |
| Applicant | MIMOSA ACOUSTICS, INC. 382 FOREST HILL WAY Mountainside, NJ 07092 |
| Contact | Patricia S Jeng |
| Correspondent | Patricia S Jeng MIMOSA ACOUSTICS, INC. 382 FOREST HILL WAY Mountainside, NJ 07092 |
| Product Code | EWO |
| CFR Regulation Number | 874.1050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-23 |
| Decision Date | 1998-05-20 |
| Summary: | summary |