SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3


Device Classification Name

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

510(k) Number K080495
Device Name SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3
Applicant
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Applicant Contact mary kruitwagen
Correspondent
PHILIPS MEDICAL SYSTEMS
3000 minuteman rd.
andover, 
MA 
01810 -1099

Correspodent Contact mary kruitwagen
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 02/22/2008
Decision Date 03/24/2008
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