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 |