Device Classification Name |
calculator, drug dose
|
510(k) Number |
K011571 |
FOIA Releasable 510(k) |
K011571
|
Device Name |
TRXF INTELLIGENT DOSING SYSTEM (IDS) -DOSING CALCULATOR SUITE |
Applicant |
THE RX FILES CORP. |
P.O. BOX 4341 |
CROFTON,
MD
21114
|
|
Applicant Contact |
YOLANDA SMITH |
Correspondent |
THE RX FILES CORP. |
P.O. BOX 4341 |
CROFTON,
MD
21114
|
|
Correspondent Contact |
YOLANDA SMITH |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 05/21/2001 |
Decision Date | 08/09/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Anesthesiology
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|