The following data is part of a premarket notification filed by Miracle-ear/dahlberg, Inc. with the FDA for Miracle-ear Model Pgc.
Device ID | K942894 |
510k Number | K942894 |
Device Name: | MIRACLE-EAR MODEL PGC |
Classification | Hearing Aid, Air Conduction |
Applicant | MIRACLE-EAR/DAHLBERG, INC. 4101 DAHLBERG DR. Golden Valley, MN 55422 |
Contact | Melanie Raska |
Correspondent | Melanie Raska MIRACLE-EAR/DAHLBERG, 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 | 1994-06-20 |
Decision Date | 1994-08-17 |