Device Classification Name |
Oximeter
|
510(k) Number |
K022193 |
Device Name |
DINAMAP PROCARE SERIES MONITOR, MODELS 100N, 200N, 300N, 400N |
Applicant |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4502 WOODLAND CORP.BLVD. |
TAMPA,
FL
33614
|
|
Applicant Contact |
MELISSA ROBINSON |
Correspondent |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
4502 WOODLAND CORP.BLVD. |
TAMPA,
FL
33614
|
|
Correspondent Contact |
MELISSA ROBINSON |
Regulation Number | 870.2700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/05/2002 |
Decision Date | 08/01/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|