The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle-ear Confidante.
Device ID | K940458 |
510k Number | K940458 |
Device Name: | MIRACLE-EAR CONFIDANTE |
Classification | Hearing Aid, Air Conduction |
Applicant | MIRACLE-EAR, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
Contact | Melanie Raska |
Correspondent | Melanie 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 | 1994-02-01 |
Decision Date | 1994-03-21 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
MIRACLE-EAR CONFIDANTE 75907868 2503031 Dead/Cancelled |
Miracle-Ear, Inc. 2000-02-02 |