The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Sunspots Pre-gelled Surface Electrodes.
| Device ID | K062198 |
| 510k Number | K062198 |
| Device Name: | SUNSPOTS PRE-GELLED SURFACE ELECTRODES |
| Classification | Electrode, Cutaneous |
| 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 | GXY |
| CFR Regulation Number | 882.1320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-08-01 |
| Decision Date | 2006-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20613994802389 | K062198 | 000 |
| 20613994327899 | K062198 | 000 |
| 20613994328056 | K062198 | 000 |
| 20613994328063 | K062198 | 000 |
| 20613994328070 | K062198 | 000 |
| 20613994328087 | K062198 | 000 |
| 20613994328094 | K062198 | 000 |
| 20613994328100 | K062198 | 000 |
| 20613994328117 | K062198 | 000 |
| 00613994329561 | K062198 | 000 |
| 00613994604965 | K062198 | 000 |
| 00613994604972 | K062198 | 000 |
| 20613994801429 | K062198 | 000 |
| 20613994801436 | K062198 | 000 |
| 20613994802365 | K062198 | 000 |
| 20613994802372 | K062198 | 000 |
| 20613994327882 | K062198 | 000 |