Device Classification Name |
calculator, drug dose
|
510(k) Number |
K121542 |
Device Name |
PICIS WEIGHT BASED DOSE CONVERTER |
Applicant |
PICIS INC. |
1835 MARKET ST, 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
JANICE HOGAN |
Correspondent |
PICIS INC. |
1835 MARKET ST, 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JANICE HOGAN |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 05/24/2012 |
Decision Date | 08/27/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|