The following data is part of a premarket notification filed by Miracle-ear, Inc. with the FDA for Audiotone Ite Hearing Aid Model Zd (xt).
Device ID | K901746 |
510k Number | K901746 |
Device Name: | AUDIOTONE ITE HEARING AID MODEL ZD (XT) |
Classification | Hearing Aid, Air Conduction |
Applicant | MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis, MN 55426 |
Contact | Kevin Kutina |
Correspondent | Kevin Kutina MIRACLE-EAR, INC. 600 SOUTH COUNTY RD. 18 Minneapolis, MN 55426 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-04-17 |
Decision Date | 1990-05-29 |