The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Axon Systems Subdermal Needle Electrodes.
| Device ID | K050194 |
| 510k Number | K050194 |
| Device Name: | AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES |
| Classification | Electrode, Needle |
| 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 | GXZ |
| CFR Regulation Number | 882.1350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-27 |
| Decision Date | 2005-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994871497 | K050194 | 000 |
| 20613994327936 | K050194 | 000 |
| 20613994327943 | K050194 | 000 |
| 20613994327950 | K050194 | 000 |
| 20613994327967 | K050194 | 000 |
| 20613994327998 | K050194 | 000 |
| 20613994470984 | K050194 | 000 |
| 00613994329530 | K050194 | 000 |
| 00613994329554 | K050194 | 000 |
| 00613994871480 | K050194 | 000 |
| 20613994327929 | K050194 | 000 |