CARESCAPE V100


Device Classification Name

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

510(k) Number K073203
Device Name CARESCAPE V100
Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 woodland corp.blvd.
tampa, 
FL 
33614

Applicant Contact karen russell
Correspondent
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 woodland corp.blvd.
tampa, 
FL 
33614

Correspodent Contact karen russell
Regulation Number 870.1025
Classification Product Code
MHX  
Date Received 11/13/2007
Decision Date 11/29/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No