Device Classification Name |
Controller, Infusion, Intravascular, Electronic
|
510(k) Number |
K905498 |
Device Name |
STAT 2 IV PUMPETTE |
Applicant |
THE MASTER MEDICAL CORP. |
201 SPEAR ST. |
SUITE 1111 |
SAN FRANCISCO,
CA
94105
|
|
Applicant Contact |
CHARLES L MORIN |
Correspondent |
THE MASTER MEDICAL CORP. |
201 SPEAR ST. |
SUITE 1111 |
SAN FRANCISCO,
CA
94105
|
|
Correspondent Contact |
CHARLES L MORIN |
Regulation Number | 880.5725
|
Classification Product Code |
|
Date Received | 12/07/1990 |
Decision Date | 04/16/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|