The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Epochxp Neurological Workstation,epochxp Lite Neurological Workstation.
Device ID | K032741 |
510k Number | K032741 |
Device Name: | EPOCHXP NEUROLOGICAL WORKSTATION,EPOCHXP LITE NEUROLOGICAL WORKSTATION |
Classification | Stimulator, Electrical, Evoked Response |
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 | GWF |
Subsequent Product Code | GWE |
Subsequent Product Code | GWJ |
Subsequent Product Code | GWQ |
Subsequent Product Code | OLT |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-09-04 |
Decision Date | 2003-12-16 |
Summary: | summary |