The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Am 400.
| Device ID | K961084 |
| 510k Number | K961084 |
| Device Name: | AM 400 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ELECTONE, INC. 1124 FLORIDA CENTRAL PKWY. Longwood, FL 32750 |
| Contact | Jim Nee |
| Correspondent | Jim Nee ELECTONE, INC. 1124 FLORIDA CENTRAL PKWY. Longwood, FL 32750 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-03-19 |
| Decision Date | 1996-04-18 |