The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Personal Amplifier.
| Device ID | K832168 |
| 510k Number | K832168 |
| Device Name: | PERSONAL AMPLIFIER |
| Classification | Hearing Aid, Air Conduction |
| Applicant | ELECTONE, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-06 |
| Decision Date | 1983-11-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() PERSONAL AMPLIFIER 75677372 2415223 Dead/Cancelled |
SIEMENS HEARING INSTRUMENTS, INC. 1999-04-08 |
![]() PERSONAL AMPLIFIER 74278073 1749997 Dead/Cancelled |
ELECTONE, INC. 1992-05-22 |