The following data is part of a premarket notification filed by Stanton Magnetics, Inc. with the FDA for Addvox Bone Conductor Amplifier Speaker System.
| Device ID | K901503 |
| 510k Number | K901503 |
| Device Name: | ADDVOX BONE CONDUCTOR AMPLIFIER SPEAKER SYSTEM |
| Classification | Larynx, Artificial (battery-powered) |
| Applicant | STANTON MAGNETICS, INC. 101 SUNNYSIDE BLVD. Plainview, NY 11803 |
| Contact | Bidwell, Iii |
| Correspondent | Bidwell, Iii STANTON MAGNETICS, INC. 101 SUNNYSIDE BLVD. Plainview, NY 11803 |
| Product Code | ESE |
| CFR Regulation Number | 874.3375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-30 |
| Decision Date | 1990-06-28 |