Device Classification Name |
calculator, drug dose
|
510(k) Number |
K161865 |
Device Name |
iSage Rx (iSage Rx Basal Insulin Titration) |
Applicant |
iSag Rx, Inc. |
206 ALAPOCAS DR |
WILMINGTON,
DE
19803
|
|
Applicant Contact |
RYAN SYSKO |
Correspondent |
iSag Rx, Inc. |
206 ALAPOCAS DR |
WILMINGTON,
DE
19803
|
|
Correspondent Contact |
RYAN SYSKO |
Regulation Number | 868.1890
|
Classification Product Code |
|
Date Received | 07/07/2016 |
Decision Date | 03/07/2017 |
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
|