The following data is part of a premarket notification filed by Kindel & Anderson with the FDA for Rionet Hearing Aid.
Device ID | K802812 |
510k Number | K802812 |
Device Name: | RIONET HEARING AID |
Classification | Hearing Aid, Master |
Applicant | KINDEL & ANDERSON 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KHL |
CFR Regulation Number | 874.3330 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-11-07 |
Decision Date | 1980-11-26 |