Device Classification Name |
Pump, Infusion, Enteral
|
510(k) Number |
K031199 |
Device Name |
ENTERALITE INFINITY ENTERAL FEEDING PUMP |
Applicant |
ZEVEX INTL., INC. |
16787 BERNARDO CENTER DR. |
SUITE A-1 |
SAN DIEGO,
CA
92128
|
|
Applicant Contact |
SEAN M CURRY |
Correspondent |
ZEVEX INTL., INC. |
16787 BERNARDO CENTER DR. |
SUITE A-1 |
SAN DIEGO,
CA
92128
|
|
Correspondent Contact |
SEAN M CURRY |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 04/14/2003 |
Decision Date | 07/09/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|