SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8


Device Classification Name

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

510(k) Number K103652
Device Name SURESIGNS VM SERIES PATIENT MONITORS, SURESIGNS VM4, SURESIGNS VM6, AND SURESIGNS VM8
Applicant
PHILIPS MEDICAL SYSTESMS
300 minuteman road
andover, 
MA 
01810 -1099

Applicant Contact lawrence milana
Correspondent
PHILIPS MEDICAL SYSTESMS
300 minuteman road
andover, 
MA 
01810 -1099

Correspodent Contact lawrence milana
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 12/14/2010
Decision Date 01/13/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No