The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Audiotone Model A97.
| Device ID | K920092 |
| 510k Number | K920092 |
| Device Name: | AUDIOTONE MODEL A97 |
| Classification | Latex Patient Examination Glove |
| Applicant | MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
| Contact | Kevin L Kutina |
| Correspondent | Kevin L Kutina MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
| Product Code | LYY |
| CFR Regulation Number | 880.6250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-08 |
| Decision Date | 1992-01-28 |