The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Orthomon.
| Device ID | K061113 |
| 510k Number | K061113 |
| Device Name: | ORTHOMON |
| Classification | Stimulator, Electrical, Evoked Response |
| Applicant | AXON SYSTEMS, INC. 400-2200 OSER AVE. Hauppauge, NY 11788 |
| Contact | Howard Bailin |
| Correspondent | Howard Bailin AXON SYSTEMS, INC. 400-2200 OSER AVE. Hauppauge, NY 11788 |
| Product Code | GWF |
| CFR Regulation Number | 882.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-21 |
| Decision Date | 2006-05-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994480129 | K061113 | 000 |
| 00643169071643 | K061113 | 000 |
| 00643169071629 | K061113 | 000 |
| 20613994327806 | K061113 | 000 |
| 00763000384197 | K061113 | 000 |
| 00763000384180 | K061113 | 000 |