The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Dahlberg Model Lu Bte Hearing Aid.
| Device ID | K911063 |
| 510k Number | K911063 |
| Device Name: | DAHLBERG MODEL LU BTE HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis, MN 55426 |
| Contact | Kevin L Kutina |
| Correspondent | Kevin 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 | 1991-03-11 |
| Decision Date | 1991-03-21 |