OMNI II PATIENT MONITOR


Device Classification Name

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

510(k) Number K103737
Device Name OMNI II PATIENT MONITOR
Applicant
INFINIUM MEDICAL
962 allegro ln.
apollo beach, 
FL 
33572

Applicant Contact john obrien
Correspondent
INFINIUM MEDICAL
962 allegro ln.
apollo beach, 
FL 
33572

Correspodent Contact john obrien
Regulation Number 870.2300
Classification Product Code
MWI  
Date Received 12/22/2010
Decision Date 06/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No