The following data is part of a premarket notification filed by Ivenix, Inc. with the FDA for Invenix Infusion System (iis).
| Device ID | K183311 |
| 510k Number | K183311 |
| Device Name: | Invenix Infusion System (IIS) |
| Classification | Pump, Infusion |
| Applicant | Ivenix, Inc. 50 High St., Suite 50 North Andover, MA 01845 |
| Contact | John J. Sokolowski |
| Correspondent | John J. Sokolowski Ivenix, Inc. 50 High St., Suite 50 North Andover, MA 01845 |
| Product Code | FRN |
| Subsequent Product Code | FPA |
| Subsequent Product Code | PHC |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-29 |
| Decision Date | 2019-06-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20811505030157 | K183311 | 000 |
| 10811505030211 | K183311 | 000 |
| 00811505030351 | K183311 | 000 |
| 00811505030344 | K183311 | 000 |
| 00811505030320 | K183311 | 000 |
| 00811050530399 | K183311 | 000 |
| 00811050530375 | K183311 | 000 |
| 00811505030399 | K183311 | 000 |
| 00811505030375 | K183311 | 000 |
| 00811505030443 | K183311 | 000 |
| 10811505030228 | K183311 | 000 |
| 10811505030235 | K183311 | 000 |
| 00811505030177 | K183311 | 000 |
| 00811505030122 | K183311 | 000 |
| 00811505030108 | K183311 | 000 |
| 20811505030072 | K183311 | 000 |
| 20811505030058 | K183311 | 000 |
| 20811505030034 | K183311 | 000 |
| 00811505030023 | K183311 | 000 |
| 00811505030016 | K183311 | 000 |
| 00811505030009 | K183311 | 000 |
| 00811505030184 | K183311 | 000 |
| 00811505030436 | K183311 | 000 |