The following data is part of a premarket notification filed by Isag Rx, Inc. with the FDA for Isage Rx (isage Rx Basal Insulin Titration).
| Device ID | K161865 |
| 510k Number | K161865 |
| Device Name: | ISage Rx (iSage Rx Basal Insulin Titration) |
| Classification | Calculator, Drug Dose |
| Applicant | iSag Rx, Inc. 206 ALAPOCAS DR Wilmington, DE 19803 |
| Contact | Ryan Sysko |
| Correspondent | Ryan Sysko iSag Rx, Inc. 206 ALAPOCAS DR Wilmington, DE 19803 |
| Product Code | NDC |
| CFR Regulation Number | 868.1890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-07 |
| Decision Date | 2017-03-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850006610006 | K161865 | 000 |