The following data is part of a premarket notification filed by Vicon Instrument Co. with the FDA for Finetone Model Vi Hearing Aid.
Device ID | K811751 |
510k Number | K811751 |
Device Name: | FINETONE MODEL VI HEARING AID |
Classification | Hearing Aid, Air Conduction |
Applicant | VICON INSTRUMENT CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-06-22 |
Decision Date | 1981-07-15 |