The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Personal Amplifier Communicator Premium.
Device ID | K853606 |
510k Number | K853606 |
Device Name: | PERSONAL AMPLIFIER COMMUNICATOR PREMIUM |
Classification | Hearing Aid, Air Conduction |
Applicant | ELECTONE, INC. P.O. BOX 910 Winter Park, FL 32790 |
Contact | Michael D Underhill |
Correspondent | Michael D Underhill 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 | 1985-08-28 |
Decision Date | 1985-09-23 |