The following data is part of a premarket notification filed by Amplifon S.p.a. with the FDA for Amplaid A315 And A319.
Device ID | K983915 |
510k Number | K983915 |
Device Name: | AMPLAID A315 AND A319 |
Classification | Audiometer |
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 | EWO |
CFR Regulation Number | 874.1050 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-11-04 |
Decision Date | 1999-01-29 |
Summary: | summary |