510(k) K243354
- Device
- Remunity System
- Applicant
- Deka Research & Development Corp.
- 510(k) number
- K243354
- Product code
- QJY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-11-27
- Date received
- 2024-10-29
- Regulation
- 880.5725
- Classification name
- Infusion Pump, Drug Specific, Pharmacy-Filled
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Paul Smolenski
- Address
- 340 Commercial St. Manchester NH US 03101 03101
FDA Registration Numbers#
- 1058584
- 2219920
- 3015192982
- 3016798778
- 1220973
- 1526534
- 1420032
Source Documents#
Other 510(k) Records For Product Code QJY#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240256 | Remunity System | Deka Research and Development | 2024-06-12 |
| K202690 | Remunity Pump for Remodulin (treprostinil) Injection | Deka Research and Development | 2020-12-30 |
| K191313 | Unity Subcutaneous Infusion System for Remodulin | DEKA Research & Development | 2020-02-21 |