The following data is part of a premarket notification filed by Insulet Corporation with the FDA for Smartadjust(tm) Technology.
| Device ID | K220394 |
| 510k Number | K220394 |
| Device Name: | SmartAdjust(TM) Technology |
| Classification | Interoperable Automated Glycemic Controller |
| Applicant | Insulet Corporation 100 Nagog Park Acton, MA 01720 |
| Contact | Alexander Hamad |
| Correspondent | Alexander Hamad Insulet Corporation 100 Nagog Park Acton, MA 01720 |
| Product Code | QJI |
| CFR Regulation Number | 862.1356 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-11 |
| Decision Date | 2022-08-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10385083000565 | K220394 | 000 |