The following data is part of a premarket notification filed by National Hearing Aid Dist., Inc. with the FDA for Listenaider Ii.
| Device ID | K952057 |
| 510k Number | K952057 |
| Device Name: | LISTENAIDER II |
| Classification | Device, Assistive Listening |
| Applicant | NATIONAL HEARING AID DIST., INC. 301 U.S. RT. 1 Scarborough, ME 04074 |
| Contact | Jeffrey A Mclaughlin |
| Correspondent | Jeffrey A Mclaughlin NATIONAL HEARING AID DIST., INC. 301 U.S. RT. 1 Scarborough, ME 04074 |
| Product Code | LZI |
| CFR Regulation Number | 874.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-02 |
| Decision Date | 1995-06-21 |