The following data is part of a premarket notification filed by Beltone Electronics Corp. with the FDA for Beltone Composer 2000 Bte Hp.
Device ID | K955930 |
510k Number | K955930 |
Device Name: | BELTONE COMPOSER 2000 BTE HP |
Classification | Hearing Aid, Air Conduction |
Applicant | BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST. Chicago, IL 60646 |
Contact | Robert A Kratochvil |
Correspondent | Robert A Kratochvil BELTONE ELECTRONICS CORP. 4201 WEST VICTORIA ST. Chicago, IL 60646 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-12-21 |
Decision Date | 1996-03-01 |
Summary: | summary |