The following data is part of a premarket notification filed by Singer Medical Products, Inc. with the FDA for Axostim Nerve Stimulator, Modification.
| Device ID | K905035 |
| 510k Number | K905035 |
| Device Name: | AXOSTIM NERVE STIMULATOR, MODIFICATION |
| Classification | Stimulator, Nerve |
| Applicant | SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
| Contact | Deborah L Singer |
| Correspondent | Deborah L Singer SINGER MEDICAL PRODUCTS, INC. 790 MAPLE LN. Bensenville, IL 60106 |
| Product Code | ETN |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-10-25 |
| Decision Date | 1991-04-19 |