The following data is part of a premarket notification filed by Unitron Industries, Inc. with the FDA for Unitron Model Sound F/x Programmable Ite (sf/x Programmable).
| Device ID | K970519 |
| 510k Number | K970519 |
| Device Name: | UNITRON MODEL SOUND F/X PROGRAMMABLE ITE (SF/X PROGRAMMABLE) |
| Classification | Hearing Aid, Air Conduction |
| Applicant | UNITRON INDUSTRIES, INC. 3555 WALNUT ST. P.O. BOX 5010 Port Huron, MI 48061 -5010 |
| Contact | Jerry G Johnson |
| Correspondent | Jerry G Johnson UNITRON INDUSTRIES, INC. 3555 WALNUT ST. P.O. BOX 5010 Port Huron, MI 48061 -5010 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-11 |
| Decision Date | 1997-04-24 |
| Summary: | summary |