The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Am130 Agc-o (behind The Ear) Hearing Aid.
| Device ID | K910148 |
| 510k Number | K910148 |
| Device Name: | AM130 AGC-O (BEHIND THE EAR) HEARING AID |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ELECTONE, INC. P.O. BOX 910 Winter Park, FL 32790 |
| Contact | Jim Nee |
| Correspondent | Jim Nee ELECTONE, INC. P.O. BOX 910 Winter Park, FL 32790 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-14 |
| Decision Date | 1991-01-29 |