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 |