The following data is part of a premarket notification filed by Ear-tronics, Inc. with the FDA for Custom, In-the-ear Hearing Aid.
| Device ID | K821390 |
| 510k Number | K821390 |
| Device Name: | CUSTOM, IN-THE-EAR HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | EAR-TRONICS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-11 |
| Decision Date | 1982-06-07 |