The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle-ear Or Audiotone.
| Device ID | K964669 |
| 510k Number | K964669 |
| Device Name: | MIRACLE-EAR OR AUDIOTONE |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
| Contact | Melanie Raska |
| Correspondent | Melanie Raska MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-11-21 |
| Decision Date | 1996-12-26 |
| Summary: | summary |