The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Disposable Monopolar And Bipolar Stimulator Probes.
| Device ID | K062996 |
| 510k Number | K062996 |
| Device Name: | DISPOSABLE MONOPOLAR AND BIPOLAR STIMULATOR PROBES |
| 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 | 2006-10-02 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613994910851 | K062996 | 000 |
| 20613994327820 | K062996 | 000 |
| 20613994327837 | K062996 | 000 |
| 20613994327844 | K062996 | 000 |
| 00613994329523 | K062996 | 000 |
| 20613994802501 | K062996 | 000 |
| 20613994802518 | K062996 | 000 |
| 00613994870865 | K062996 | 000 |
| 00613994870872 | K062996 | 000 |
| 00613994870889 | K062996 | 000 |
| 00613994871046 | K062996 | 000 |
| 00613994871084 | K062996 | 000 |
| 00613994877376 | K062996 | 000 |
| 20613994327813 | K062996 | 000 |