The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle Ear Confidante.
Device ID | K943825 |
510k Number | K943825 |
Device Name: | MIRACLE EAR CONFIDANTE |
Classification | Hearing Aid, Air Conduction |
Applicant | MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
Contact | Melainie Raska |
Correspondent | Melainie Raska MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-08-05 |
Decision Date | 1994-09-21 |