MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES


Device Classification Name

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

510(k) Number K073462
Device Name MODIFICATION TO DASH 3000, 4000, 5000 MONITOR AND ACCESSORIES
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
86 pilgrin rd.
needham, 
MA 
02492

Applicant Contact joel kent
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
86 pilgrin rd.
needham, 
MA 
02492

Correspodent Contact joel kent
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 12/10/2007
Decision Date 01/11/2008
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