The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Audiotone Model Ffi Ite Hearing Aid.
| Device ID | K901556 |
| 510k Number | K901556 |
| Device Name: | AUDIOTONE MODEL FFI ITE HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis, MN 55426 |
| Contact | Kevin Kutina |
| Correspondent | Kevin 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 | 1990-04-03 |
| Decision Date | 1990-04-18 |