The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Miracle Ear Model Sk In-the-ear Hearing Aid.
Device ID | K900238 |
510k Number | K900238 |
Device Name: | MIRACLE EAR MODEL SK IN-THE-EAR HEARING AID |
Classification | Hearing Aid, Air Conduction |
Applicant | MIRACLE-EAR, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
Contact | Kevin L Kutina |
Correspondent | Kevin L Kutina MIRACLE-EAR, INC. 7731 COUNTRY CLUB DR. Golden Valley, MN 55427 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-01-17 |
Decision Date | 1990-02-22 |