OMNI PATIENT MONITOR


Device Classification Name

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

510(k) Number K112329
Device Name OMNI PATIENT MONITOR
Applicant
INFINIUM MEDICAL
962 allegro ln.
apollo beach, 
FL 
33572

Applicant Contact john o’brien
Correspondent
INFINIUM MEDICAL
962 allegro ln.
apollo beach, 
FL 
33572

Correspodent Contact john o’brien
Regulation Number 870.2300
Classification Product Code
MWI  
Subsequent Product Codes
BZQ   DPS   DQA   DXN   FLL  
Date Received 08/12/2011
Decision Date 09/08/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No