The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Microvox Resonal Fm System.
Device ID | K941768 |
510k Number | K941768 |
Device Name: | PHONAK MICROVOX RESONAL FM SYSTEM |
Classification | Hearing Aid, Group And Auditory Trainer |
Applicant | PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville, IL 60566 |
Contact | Bill Lesiecki |
Correspondent | Bill Lesiecki PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville, IL 60566 |
Product Code | EPF |
CFR Regulation Number | 874.3320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-04-11 |
Decision Date | 1994-06-24 |