MINI TELEMETRY SYSTEM


Device Classification Name

system, monitoring, perinatal

510(k) Number K110556
Device Name MINI TELEMETRY SYSTEM
Applicant
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 goman road
laurel, 
MD 
20723 -5800

Applicant Contact agata smieja
Correspondent
WIPRO GE HEALTHCARE PRIVATE, LTD.
8880 goman road
laurel, 
MD 
20723 -5800

Correspodent Contact agata smieja
Regulation Number 884.2740
Classification Product Code
HGM  
Date Received 02/28/2011
Decision Date 07/19/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Obstetrics/Gynecology

510k Review Panel

Obstetrics/Gynecology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No