The following data is part of a premarket notification filed by Beltone Electronics Corp. with the FDA for Minuet Masker; Jubilee Masker.
Device ID | K800784 |
510k Number | K800784 |
Device Name: | MINUET MASKER; JUBILEE MASKER |
Classification | Masker, Tinnitus |
Applicant | BELTONE ELECTRONICS CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | KLW |
CFR Regulation Number | 874.3400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1980-04-08 |
Decision Date | 1980-04-29 |