The following data is part of a premarket notification filed by Phonak, Inc. with the FDA for Phonak Microlink, Personal Fm Receiver.
| Device ID | K964035 |
| 510k Number | K964035 |
| Device Name: | PHONAK MICROLINK, PERSONAL FM RECEIVER |
| Classification | Hearing Aid, Air Conduction |
| Applicant | PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 Naperville, IL 60566 |
| Contact | Helmut Ermann |
| Correspondent | Helmut Ermann PHONAK, INC. 850 E. DIEHL RD. P.O. BOX 3017 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 | 1996-10-08 |
| Decision Date | 1996-12-04 |
| Summary: | summary |