LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812


Device Classification Name

electrode, needle

510(k) Number K023472
Device Name LOW PROFILE EEG NEEDLE ELECTRODE, MODELS 112-812-18TP, 112-812-48TP, 112-812-60TP, 112-812-72TP, 112-812-96TP, 112-812
Original Applicant
CLASS A ENTERPRISES, INC.
p.o. box 401964-16039
walnut st. ste c
hesperia, 
CA 
92340

Original Contact samantha l draper
Regulation Number 882.1350
Classification Product Code
GXZ  
Date Received 10/16/2002
Decision Date 03/18/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No