PHOENIX DIGITAL EEG


codes

Device Classification Name

full-montage standard electroencephalograph

510(k) Number K002316
Device Name PHOENIX DIGITAL EEG
Original Applicant
AXON SYSTEMS, INC.
400-2200 oser ave.
hauppauge, 
NY 
11788

Original Contact howard bailin
Regulation Number 882.1400
Classification Product Code
GWQ  
Date Received 07/31/2000
Decision Date 10/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No