The following data is part of a premarket notification filed by Miracle-ear/dahlberg, Inc. with the FDA for Model Um In-the-canal Hearing Aid.
| Device ID | K862101 |
| 510k Number | K862101 |
| Device Name: | MODEL UM IN-THE-CANAL HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | MIRACLE-EAR/DAHLBERG, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
| Contact | Robert E Meyer |
| Correspondent | Robert E Meyer MIRACLE-EAR/DAHLBERG, 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 | 1986-06-02 |
| Decision Date | 1986-06-23 |