Device Classification Name |
pump, infusion
|
510(k) Number |
K070529 |
Device Name |
AFF (MARK I) VOLUMETRIC INFUSION PUMP |
Applicant |
DEFINITIVE MEDICAL TECHNOLOGIES, LTD. |
4 HAMELACHA ST. |
NORTH INDUSTRIAL ZONE |
LOD,
IL
71520
|
|
Applicant Contact |
BOAZ BARTOV |
Correspondent |
KEMA QUALITY B.V. |
4377 COUNTY LINE ROAD |
CHALFONT,
PA
18914
|
|
Correspondent Contact |
J A VAN VUGT |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 02/23/2007 |
Decision Date | 05/08/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|