Device Classification Name |
pump, infusion
|
510(k) Number |
K061325 |
Device Name |
BODYGAURD PAIN MANAGER INFUSION SYSTEM |
Applicant |
CAESAREA MEDICAL ELECTRONICS LTD. |
16 SHACHAM STREET |
CAESAREA INDUSTRIAL PARK |
CAESAREA,
IL
38900
|
|
Applicant Contact |
SHLOMI DINES |
Correspondent |
CAESAREA MEDICAL ELECTRONICS LTD. |
16 SHACHAM STREET |
CAESAREA INDUSTRIAL PARK |
CAESAREA,
IL
38900
|
|
Correspondent Contact |
SHLOMI DINES |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 05/11/2006 |
Decision Date | 08/24/2006 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Abbreviated
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|