The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle Ear Model Sm In-the-ear Hearing Aid.
| Device ID | K900237 |
| 510k Number | K900237 |
| Device Name: | MIRACLE EAR MODEL SM IN-THE-EAR HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MIRACLE-EAR, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
| Contact | Kevin L Kutina |
| Correspondent | Kevin L Kutina MIRACLE-EAR, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-17 |
| Decision Date | 1990-02-22 |