STAR 50 N


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K103686
Device Name STAR 50 N
Applicant
LARSEN & TOUBRO LIMITED
1468 harwell ave.
crofton, 
MD 
21114

Applicant Contact e. j smith
Correspondent
LARSEN & TOUBRO LIMITED
1468 harwell ave.
crofton, 
MD 
21114

Correspodent Contact e. j smith
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 12/17/2010
Decision Date 03/15/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No