The following data is part of a premarket notification filed by Axon Systems, Inc. with the FDA for Eclipse Neurological Workstation.
Device ID | K050798 |
510k Number | K050798 |
Device Name: | ECLIPSE 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 |
CFR Regulation Number | 882.1870 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-03-29 |
Decision Date | 2005-08-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00643169072053 | K050798 | 000 |
00643169553057 | K050798 | 000 |
00643169553071 | K050798 | 000 |
00643169553088 | K050798 | 000 |
00643169793873 | K050798 | 000 |
00643169020177 | K050798 | 000 |
00643169020191 | K050798 | 000 |
00643169071704 | K050798 | 000 |
00643169071711 | K050798 | 000 |
00643169071735 | K050798 | 000 |
00643169071742 | K050798 | 000 |
00643169071759 | K050798 | 000 |
00643169071773 | K050798 | 000 |
00643169071827 | K050798 | 000 |
00643169071865 | K050798 | 000 |
00643169071872 | K050798 | 000 |
00643169071933 | K050798 | 000 |
00643169071940 | K050798 | 000 |
00643169523548 | K050798 | 000 |