The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Hearing Aid 47 Series.
Device ID | K872555 |
510k Number | K872555 |
Device Name: | HEARING AID 47 SERIES |
Classification | Hearing Aid, Air Conduction |
Applicant | ELECTONE, INC. P.O. BOX 910 Winter Park, FL 32790 |
Contact | Fred A Wilson |
Correspondent | Fred A Wilson 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 | 1987-06-29 |
Decision Date | 1987-07-10 |