The following data is part of a premarket notification filed by Amplifon S.p.a. with the FDA for Amplaid Mk12.
| Device ID | K971740 |
| 510k Number | K971740 |
| Device Name: | AMPLAID MK12 |
| Classification | Stimulator, Electrical, Evoked Response |
| 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 | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-12 |
| Decision Date | 1998-03-16 |
| Summary: | summary |