The following data is part of a premarket notification filed by Authorized Hearing Systems, Inc. with the FDA for Alpha All-in-the-ear Hearing Aid.
| Device ID | K862169 |
| 510k Number | K862169 |
| Device Name: | ALPHA ALL-IN-THE-EAR HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | AUTHORIZED HEARING SYSTEMS, INC. P.O. BOX 309 Levittown, PA 19058 |
| Contact | Amber J Smith |
| Correspondent | Amber J Smith AUTHORIZED HEARING SYSTEMS, INC. P.O. BOX 309 Levittown, PA 19058 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-09 |
| Decision Date | 1986-07-22 |