DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N


Device Classification Name

monitor,physiological,patient(without arrhythmia detection or alarms)

510(k) Number K021435
Device Name DINAMAP PRO SERIES MONITOR, MODELS 110N,210N,310N,410N
Original Applicant
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
4502 woodland corp.blvd.
tampa, 
FL 
33614

Original Contact melissa robinson
Regulation Number 870.2300
Classification Product Code
MWI  
Subsequent Product Code
DQA  
Date Received 05/06/2002
Decision Date 05/22/2002
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