INTELLIVUE MX40 PATIENT MONITOR


Device Classification Name

monitor, physiological, patient(with arrhythmia detection or alarms)

510(k) Number K103646
Device Name INTELLIVUE MX40 PATIENT MONITOR
Applicant
PHILLIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Applicant Contact claire arakaki
Correspondent
PHILLIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Correspodent Contact claire arakaki
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 12/14/2010
Decision Date 01/07/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls