The following data is part of a premarket notification filed by Singer Medical Products, Inc. with the FDA for Modified Axostim.
| Device ID | K896368 |
| 510k Number | K896368 |
| Device Name: | MODIFIED AXOSTIM |
| Classification | Stimulator, Nerve, Battery-powered |
| Applicant | SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
| Contact | James I Beck |
| Correspondent | James I Beck SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
| Product Code | BXN |
| CFR Regulation Number | 868.2775 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-11-06 |
| Decision Date | 1989-11-27 |