The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Model 800, Behind-the-ear Hearing Aid.
| Device ID | K911706 |
| 510k Number | K911706 |
| Device Name: | MODEL 800, BEHIND-THE-EAR HEARING AID |
| 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 | 1991-04-16 |
| Decision Date | 1991-05-17 |