The following data is part of a premarket notification filed by National Hearing Aid Dist., Inc. with the FDA for Audiphon, Model H-11.
| Device ID | K935458 |
| 510k Number | K935458 |
| Device Name: | AUDIPHON, MODEL H-11 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | NATIONAL HEARING AID DIST., INC. 145 TREMONT ST. Boston, MA 02111 |
| Contact | Anne Mccarthy |
| Correspondent | Anne Mccarthy NATIONAL HEARING AID DIST., INC. 145 TREMONT ST. Boston, MA 02111 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-12 |
| Decision Date | 1994-01-05 |