PC-180 / PRINCE 180 EASY ECG MONITOR


Device Classification Name

recorder, magnetic tape, medical

510(k) Number K073152
Device Name PC-180 / PRINCE 180 EASY ECG MONITOR
Applicant
SHENZHEN CREATIVE INDUSTRY CO., LTD
2/f, block 3 nanyou tian’
an industry town
shenzhen,gd, 

CN

518054

Regulation Number 870.2800
Classification Product Code
DSH  
Date Received 11/08/2007
Decision Date 01/10/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No