The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle Ear Model Ck In-the-ear Hearing Aid.
| Device ID | K900050 |
| 510k Number | K900050 |
| Device Name: | MIRACLE EAR MODEL CK IN-THE-EAR HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis, MN 55426 |
| Contact | L Kutina |
| Correspondent | L Kutina MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis, MN 55426 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-03 |
| Decision Date | 1990-03-14 |