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 |