The following data is part of a premarket notification filed by Electone, Inc. with the FDA for Pa Equalizer.
Device ID | K863787 |
510k Number | K863787 |
Device Name: | PA EQUALIZER |
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 | 1986-09-26 |
Decision Date | 1986-10-14 |