EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION


Device Classification Name

full-montage standard electroencephalograph

510(k) Number K022785
Device Name EPOCH XP NEUROLOGICAL WORKSTATION; EPOCH XP LITE NEUROLOGICAL WORKSTATION
Original Applicant
AXON SYSTEMS, INC.
400-2200 oser ave.
hauppauge, 
NY 
11788

Original Contact howard bailin
Regulation Number 882.1400
Classification Product Code
GWQ  
Subsequent Product Codes
GWE   GWF   GWJ   OLT   ORT  
Date Received 08/22/2002
Decision Date 10/09/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No