The following data is part of a premarket notification filed by Deka Research & Development with the FDA for Unity Subcutaneous Infusion System For Remodulin.
| Device ID | K191313 |
| 510k Number | K191313 |
| Device Name: | Unity Subcutaneous Infusion System For Remodulin |
| Classification | Infusion Pump, Drug Specific, Pharmacy-filled |
| Applicant | DEKA Research & Development 340 Commercial Street Manchester, NH 03101 |
| Contact | Jason Demers |
| Correspondent | Jason Demers DEKA Research & Development 340 Commercial Street Manchester, NH 03101 |
| Product Code | QJY |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-15 |
| Decision Date | 2020-02-21 |