The following data is part of a premarket notification filed by Bell Hearing Instruments, Inc. with the FDA for Vip.
Device ID | K950080 |
510k Number | K950080 |
Device Name: | VIP |
Classification | Hearing Aid, Air Conduction |
Applicant | BELL HEARING INSTRUMENTS, INC. 2796 SUMMERDALE DR. Clearwater, FL 33761 |
Contact | William A Bell |
Correspondent | William A Bell BELL HEARING INSTRUMENTS, INC. 2796 SUMMERDALE DR. Clearwater, FL 33761 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-10 |
Decision Date | 1995-02-08 |