The following data is part of a premarket notification filed by National Hearing Aid Dist., Inc. with the FDA for Tondi, Models U-03, U-2m1, U-2m4, Ka-01, Ka-02, Ka-03, Ka-03a, Ka-04, Ka-04a, Ka-05.
| Device ID | K971296 |
| 510k Number | K971296 |
| Device Name: | TONDI, MODELS U-03, U-2M1, U-2M4, KA-01, KA-02, KA-03, KA-03A, KA-04, KA-04A, KA-05 |
| Classification | Hearing Aid, Air Conduction |
| Applicant | NATIONAL HEARING AID DIST., INC. 301 U.S. RT. 1 Scarborough, ME 04074 |
| Contact | Paul Menezes |
| Correspondent | Paul Menezes NATIONAL HEARING AID DIST., INC. 301 U.S. RT. 1 Scarborough, ME 04074 |
| Product Code | ESD |
| CFR Regulation Number | 874.3300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-07 |
| Decision Date | 1997-06-20 |