CONDUCTIVE GEL FOR ULTRASOUND


 

Device Classification Name media, electroconductive
510(k) Number K002832
Device Name CONDUCTIVE GEL FOR ULTRASOUND
Original Applicant
SKYLARK DEVICE & SYSTEMS CO., LTD
34 chung shan north rd.,
12th fl., sec. 3
taipei,

 

TW

Original Contactgeorge k.c. chenRegulation Number882.1275Classification Product Code

GYB

Date Received09/11/2000Decision Date08/06/2001Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

TypeTraditionalReviewed by Third PartyNoCombination Product

No