MAX PULSE SYSTEM


Device Classification Name

plethysmograph, photoelectric, pneumatic or hydraulic

510(k) Number K110374
Device Name MAX PULSE SYSTEM
Applicant
MEDICORE CO., LTD.
3f, samwoo b/d, 339-2, jamsil
dong, songpa-gu
seoul, 

KR

Applicant Contact yoo byung-kuk
Regulation Number 870.2780
Classification Product Code
JOM  
Date Received 02/09/2011
Decision Date 06/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No