The following data is part of a premarket notification filed by Amplifon S.p.a. with the FDA for Amplaid Am50.
| Device ID | K974235 |
| 510k Number | K974235 |
| Device Name: | AMPLAID AM50 |
| Classification | Tester, Auditory Impedance |
| Applicant | AMPLIFON S.P.A. P.O. BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm AMPLIFON S.P.A. P.O. BOX 7007 Deerfield, IL 60015 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-11-12 |
| Decision Date | 1998-02-10 |
| Summary: | summary |