| 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
|
|---|