The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Piconet2 P2 Az.
Device ID | K961622 |
510k Number | K961622 |
Device Name: | PHONAK PICONET2 P2 AZ |
Classification | Hearing Aid, Air Conduction |
Applicant | PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville, IL 60566 |
Contact | Francis K Kuk, Ph.d.,ccc-a |
Correspondent | Francis K Kuk, Ph.d.,ccc-a PHONAK, INC. 850 E. DIEHL RD. BOX 3117 Naperville, IL 60566 |
Product Code | ESD |
CFR Regulation Number | 874.3300 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-04-26 |
Decision Date | 1996-05-17 |
Summary: | summary |